Orthopaedic Device Recall Dashboard - Orthopaedic Surgery Patient Safety

The Device Recall Dashboard (the “Dashboard”) was developed by the AAOS Committee on Devices, Biologics, and Technology and the Patient Safety Committee (the “Committee”) to assist the AAOS membership in identifying Class 1 and Class 2 device recalls relevant to their orthopaedic practice. The status of the recalls are based on member volunteer stakeholders interpretation of publicly available information from the U.S. Food and Drug Administration (FDA).

The recalls of these devices on the Device Recall Dashboard reflect the Committees interpretation of the publicly available device database, and do not imply liability of safety, effectiveness, or approval of use by AAOS. Clinicians should use their own, independent medical judgment, in addition to open discussion with the patient, when developing patient care recommendations and device selection.

While the Committee intends to update the Dashboard quarterly, AAOS makes no representations or warranties that the Dashboard contains all relevant device information and/or the most up-to-date status information. Clinicians are encouraged to independently confirm whether a Class 1 or 2 device has been subject to a recall. Use of the Dashboard is subject to applicable AAOS policies, including by not limited to the AAOS Privacy Policy and Terms of Use.

Orthopaedics makes up the single largest specialty of medical devices and accounts for approximately 20 percent of all recalls issued by the FDA. It is critical that orthopaedic surgeons understand their role in improving patient safety through device surveillance.

The goal of the Device Recall Dashboard is to provide orthopaedic surgeons with timely recall information that will ensure the quality of patient care and protect the health and well-being of their patients.

Recall Event ID	Manufacturer Name	Product Name	Specialty	Recall Date	FDA Device Number	Recall Class	Manufacturer Recall Reason
93924	Synthes (USA) Products LLC	VALCP Clavicle Plate	Shoulder and Elbow; Sports Medicine	3/1/24	K201321	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	OPAL Intervertebral Cage	Spine	3/1/24	N/A	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes Hindfoot Arthrodesis Nail System	Foot and Ankle	3/1/24	K051678	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes TFNA	Trauma	3/1/24	K160167, K131548	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes RIA System	Trauma; Pediatrics	3/1/24	K111437 ; K042899 ; K013527	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes TFNA	Trauma	3/1/24	K160167 ; K131548	2	Products not sterilized, sterility cannot be confirmed
93858	United Orthopedic Corporation	USTAR II Hip System PressFit Curved Stem, RHS Ti Plasma Spray	Arthroplasty	2/29/24	K190100	2	Their is a potential that the implant curved stem may be oriented incorrectly.
93878	Acumed LLC	Acumed AcuLoc and AcuLoc 2 Wrist Plating Systems	Hand; Sports Medicine	2/29/24	N/A	2	Distribution without Pre-Market Clearance
93858	United Orthopedic Corporation	USTAR II Knee System PressFit Curved Stem, RHS Ti Plasma Spray	Arthroplasty	2/29/24	K190100	2	Their is a potential that the implant curved stem may be oriented incorrectly.
93858	United Orthopedic Corporation	USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray	Arthroplasty	2/29/24	K190100	2	Their is a potential that the implant curved stem may be oriented incorrectly.
93944	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK BiMobile Dual Mobility System EPoly Liner for 28mm Head, 70mm Shell	Arthroplasty	2/29/24	K190535	2	Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
93898	Alphatec Spine, Inc.	IdentiTi ALIF Standalone Interbody System	Spine	2/23/24	K232097	2	Due to reports of intraoperative graft bolt implantation breakages.
94092	Exactech, Inc.	Exactech Equinoxe	Shoulder and Elbow; Arthroplasty	3/29/24	K113309	2	The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
94222	DePuy Orthopaedics, Inc.	ATTUNE KNEE SYSTEM TIBIAL BASE AFFIXIUM FIXED BEARING SIZE 6	Arthroplasty	3/29/24	K202194 ; K213781 ; K232303	2	Product incorrectly labelled.
94078	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SPII Model Lubinus, Hip Prosthesis Stem	Arthroplasty	3/14/24	K953653	2	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
94078	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SPII Model Lubinus, Hip Prosthesis Stem	Arthroplasty	3/14/24	K953653	2	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
94078	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SPII Model Lubinus, Hip Prosthesis Stem	Arthroplasty	3/14/24	K953653	2	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
94078	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SPII Model Lubinus, Hip Prosthesis Stem	Arthroplasty	3/14/24	K953653	2	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
92500	Waldemar Link GmbH & Co. KG (Mfg Site)	EndoModel Modular Knee Prosthesis System	Arthroplasty	6/30/23	K143179	2	The firm discovered through customer complaints that device segments may not meet specifications.
92500	Waldemar Link GmbH & Co. KG (Mfg Site)	EndoModel Modular Knee Prosthesis System	Arthroplasty	6/30/23	K143179	2	The firm discovered through customer complaints that device segments may not meet specifications.
92500	Waldemar Link GmbH & Co. KG (Mfg Site)	EndoModel Modular Knee Prosthesis System	Arthroplasty	6/30/23	K143179	2	The firm discovered through customer complaints that device segments may not meet specifications.
92500	Waldemar Link GmbH & Co. KG (Mfg Site)	EndoModel Modular Knee Prosthesis System	Arthroplasty	6/30/23	K143179	2	The firm discovered through customer complaints that device segments may not meet specifications.
93507	Exactech, Inc.	Exactech Opetrak	Arthroplasty	1/18/24	K160484 ; K932690 ; K933610 ; K954208	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Truliant	Arthroplasty	1/18/24	K152170 ; K171045	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Alteon	Arthroplasty	1/18/24	K182502	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Equinoxe	Shoulder and Elbow; Arthroplasty	1/18/24	K212356	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Novation	Arthroplasty	1/18/24	K071676	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech AcuMatch	Arthroplasty	1/18/24	K173583	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Vantage	Arthroplasty	1/18/24	N/A	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Equinoxe Reverse Shoulder System	Shoulder and Elbow	1/18/24	K093275; K180632; K182536; K063569	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak Logic	Arthroplasty	1/18/24	K111400; K150890	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak Logic PS	Arthroplasty	1/18/24	K033883	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Vantage	Foot and Ankle	1/18/24	K152217	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
94276	Zimmer, Inc.	Zimmer Periarticular Locking Plate System Distal Lateral Fibula Locking Plate	Trauma; Foot and Ankle; Sports Medicine	4/30/24	K070906	2	Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss
94306	SEASPINE ORTHOPEDICS CORPORATION	Mariner RDX MIS Polyaxial Head	Spine; Sports Medicine	4/23/24	K222110	2	Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
94164	SEASPINE ORTHOPEDICS CORPORATION	SeaSpine Mariner RDX System	Spine; Trauma; Sports Medicine	4/22/24	K222110	2	Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
94310	Biomet, Inc.	Vanguard Anterior Stabilized Tibial Bearing	Arthroplasty	4/22/24	K050222	2	Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
94327	Zimmer, Inc.	NexGen CRFlex Porous Femur	Arthroplasty	4/22/24	K031061	2	Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
94288	Conformis, Inc.	Identity Imprint PS Tibial Tray	Arthroplasty	4/17/24	K210191; K231233	2	Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
92776	Alphatec Spine, Inc.	LIF AMP, Adjustable Awl	Spine	8/28/23	N/A	2	Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
92767	Smith & Nephew, Inc.	smith&nephew TRIGEN	Trauma; Sports Medicine	8/22/23	K210980; K040462	2	A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
92767	Smith & Nephew, Inc.	smith&nephew TRIGEN	Trauma; Sports Medicine	8/22/23	K040462; K210980	2	A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
92758	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK MP Monoblock Trial Stem Instruments, Sizes 14mm 25mm	Arthroplasty; Trauma	8/4/23	K183141	2	Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
92969	Encore Medical, LP	DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 35202106	Arthroplasty	9/19/23	K173723	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 50801032;	Shoulder and Elbow	9/19/23	K051075	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: Delta Ceramic Femoral Head, 44 mm 4.0 mm, REF: 40003443	Arthroplasty	9/19/23	K082844	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size3, REF: 42611030	Arthroplasty	9/19/23	K052320	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 53306108	Shoulder and Elbow	9/19/23	K172351	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
94555	Smith & Nephew Inc	OXINIUM	Arthroplasty	5/24/24	K022958; K021673	2	Packaging contained the incorrect size of femoral head from what was displayed on the label.
94405	Wishbone Medical, Inc.	WishFIX Growth Control Plating System	Pediatrics	5/10/24	K182704	2	The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.
93323	Biomet, Inc.	Zimmer	Arthroplasty; Trauma	11/21/23	K062998	2	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
93323	Biomet, Inc.	OSSTM Compress & Mini Compress Anchor Plugs	Arthroplasty; Trauma; Sports Medicine	11/21/23	K062998	2	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
93748	TriMed Inc.	Volar Bearing Plate	Hand; Trauma; Sports Medicine	1/31/24	K222637	2	Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio NRG Tibial Brg Insert Assy	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DURATION A-P LIPPED TIB.INSERT-DURAC	Arthroplasty	1/31/24	K032163; K032418; K915512	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DURATION PLASTIC PATELLA-DURACON	Arthroplasty	1/31/24	K032163; K032418; K915512	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DUR PCA MTK REV INS LFT	Arthroplasty	1/31/24	K894403; K972863	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DUR PCA MTK REV INS LFT	Arthroplasty	1/31/24	K894403; K972863	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO RECESSED PATELLA	Arthroplasty	1/31/24	K863668	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DURATION A-P LIPPED TIB.INSERT-DURAC	Arthroplasty	1/31/24	K032163; K032418; K915512	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO RECESSED PATELLA	Arthroplasty	1/31/24	K863668	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy	Arthroplasty	1/31/24	K011643	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT	Arthroplasty	1/31/24	N/A	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	P7 32MM 1O DEGREE +4MM INSERT	Arthroplasty	1/31/24	N/A	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO RECESSED PATELLA	Arthroplasty	1/31/24	K863668	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	N/A	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	N/A	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DUR PCA MTK REV INS RT	Arthroplasty	1/31/24	K894403; K972863	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	PS LIPPED TIBIAL INSERT ASSY DURACON	Arthroplasty	1/31/24	K012172	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	PS LIPPED TIBIAL INSERT ASSY DURACON	Arthroplasty	1/31/24	N/A	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SERIES II TIBIAL BEAR INSERT	Arthroplasty	1/31/24	K884398	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	PRIMARY REV.TIB.INSERT-DURACON	Arthroplasty	1/31/24	K936008	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LARGE PRIMARY REV.TIB.INSERT- DURACON	Arthroplasty	1/31/24	K936008	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	PS LIPPED TIBIAL INSERT ASSY DURACON	Arthroplasty	1/31/24	K012172	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy	Arthroplasty	1/31/24	K041591	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio NRG Tibial Brg Insert Assy	Arthroplasty	1/31/24	K030978	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	OSTEONICS TRIDENT 0 deg POLY INSERT	Arthroplasty	1/31/24	N/A	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DUR PCA MTK REV INS RT	Arthroplasty	1/31/24	K894403; K972863	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	TIBIAL BEARING INSERT SERIES P-S I ASSY	Arthroplasty	1/31/24	K914565	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO RECESSED PATELLA-	Arthroplasty	1/31/24	K863668	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy	Arthroplasty	1/31/24	K011643	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	OSTEONICS TRIDENT 0 deg POLY INSERT	Arthroplasty	1/31/24	N/A	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SERIES II TIBIAL BEAR INSERT	Arthroplasty	1/31/24	K884398	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	P7 28MM 10 DEGREE +4MM INSERT	Arthroplasty	1/31/24	N/A	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93738	XTANT Medical Holdings, Inc	Cortera Spinal Fixation System	Spine	1/29/24	K221403	2	Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
93729	FX SHOULDER	CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10 TILT 32mm	Shoulder and Elbow	1/29/24	K191146	2	Centered glenosphere box may contain an eccentric glenosphere.
93662	Waldemar Link GmbH & Co. KG (Mfg Site)	Link EndoModel Patella Glide Resection Guide	Arthroplasty	1/18/24	N/A	2	Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time
93650	Zimmer Biomet Spine Inc.	Vitality Spinal Fixation System	Spine	1/4/24	K150896	2	Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.
93623	Encore Medical, LP	Reverse Shoulder System e, RSP Humeral Socket Insert	Shoulder and Elbow; Sports Medicine	1/2/24	K051075	2	Mislabeling
93623	Encore Medical, LP	Domed TriPeg Patella, 38x9mm, E	Arthroplasty	1/2/24	K113756	2	Mislabeling
93507	Exactech, Inc.	Exactech Novation	Arthroplasty	1/18/24	K071676	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak	Arthroplasty	1/18/24	K160484; K932690; K933610; K954208	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Truliant	Arthroplasty	1/18/24	K152170; K171045	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Alteon	Arthroplasty	1/18/24	K182502	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Truliant, ActivitE	Arthroplasty	1/18/24	K223252	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Equinoxe	Shoulder and Elbow; Sports Medicine	1/18/24	K212356	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Vantage	Foot and Ankle	1/18/24	K152217	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech AcuMatch	Arthroplasty	1/18/24	K173583	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Vantage	Foot and Ankle	1/18/24	N/A	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Equinoxe Reverse Shoulder System	Shoulder and Elbow; Sports Medicine	1/18/24	K093275; K180632; K182536; K063569	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak Logic	Arthroplasty	1/18/24	K111400; K150890	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak Logic PS	Arthroplasty	1/18/24	K033883	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93163	Medtronic Sofamor Danek USA Inc	GRAFTON DBM	Trauma	10/25/23	K051195	2	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
93156	Smith & Nephew, Inc.	JOURNEY II BCS	Arthroplasty	10/24/23	K140555; K111711	2	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
93156	Smith & Nephew, Inc.	JOURNEY II BCS	Arthroplasty	10/24/23	K111711; K140555	2	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
93080	Encore Medical, LP	REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP	Shoulder and Elbow	10/12/23	K041066	2	Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
93098	Encore Medical, LP	EMPOWR 3D Knee System	Arthroplasty	10/12/23	K143242	2	Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
93024	Flower Orthopedics Corporation	FlexThread TM 3.2mm Cannulated Reamer	Trauma	10/6/23	K202858	2	Device is breaking while in use, potential for patients to require a revision surgery.
92681	Zimmer, Inc.	Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length	Trauma; Sports Medicine	7/28/23	K141734	2	Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock.
92621	Materialise N.V.	MRI Biomet Pin Guide for Total Knee Arthroplasty	Arthroplasty	7/20/23	K173445; K221337	2	The wrong tibia guide was included intended for a different patient case.
92567	Medtronic Sofamor Danek USA Inc	Catalyft" LS Expandable Interbody System Anterior Standalone Cage	Spine	7/10/23	K212653	2	There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
92496	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SymphoKnee System Distal Femoral Augment	Arthroplasty	7/3/23	K202924	2	Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

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