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U.S. Department of Health and Human Services

Medical Device Recalls

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ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE T... 2 03/29/2024 DePuy Orthopaedics, Inc.
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI... 2 03/20/2024 Think Surgical, Inc.
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: R... 2 02/29/2024 United Orthopedic Corporation
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153... 2 02/29/2024 United Orthopedic Corporation
Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROG... 1 02/25/2024 MEDLINE INDUSTRIES, LP - Northfield
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-4... 2 01/31/2024 Howmedica Osteonics Corp.
TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291... 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032 2 01/31/2024 Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515 2 01/31/2024 Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524 2 01/31/2024 Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324 2 01/31/2024 Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-... 2 01/31/2024 Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-... 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Numbe... 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number:... 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number:... 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number:... 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number... 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: ... 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number:... 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910 2 01/31/2024 Howmedica Osteonics Corp.
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908 ... 2 01/31/2024 Howmedica Osteonics Corp.
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910 ... 2 01/31/2024 Howmedica Osteonics Corp.
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number... 2 01/31/2024 Howmedica Osteonics Corp.
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 62... 2 01/31/2024 Howmedica Osteonics Corp.
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number:... 2 01/31/2024 Howmedica Osteonics Corp.
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107 2 01/31/2024 Howmedica Osteonics Corp.
P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307 2 01/31/2024 Howmedica Osteonics Corp.
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028 2 01/31/2024 Howmedica Osteonics Corp.
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228 2 01/31/2024 Howmedica Osteonics Corp.
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231 2 01/31/2024 Howmedica Osteonics Corp.
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-... 2 01/31/2024 Howmedica Osteonics Corp.
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-... 2 01/31/2024 Howmedica Osteonics Corp.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-... 2 01/31/2024 Howmedica Osteonics Corp.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-... 2 01/31/2024 Howmedica Osteonics Corp.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0... 2 01/31/2024 Howmedica Osteonics Corp.
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031 2 01/31/2024 Howmedica Osteonics Corp.
LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4... 2 01/31/2024 Howmedica Osteonics Corp.
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642... 2 01/31/2024 Howmedica Osteonics Corp.
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642... 2 01/31/2024 Howmedica Osteonics Corp.
DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2... 2 01/31/2024 Howmedica Osteonics Corp.
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609 2 01/31/2024 Howmedica Osteonics Corp.
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611 2 01/31/2024 Howmedica Osteonics Corp.
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709 2 01/31/2024 Howmedica Osteonics Corp.
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711 2 01/31/2024 Howmedica Osteonics Corp.
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1... 2 01/31/2024 Howmedica Osteonics Corp.
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-... 2 01/31/2024 Howmedica Osteonics Corp.
Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit num... 2 01/26/2024 American Contract Systems, Inc.
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 2 01/25/2024 Ossur H / F
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009 2 01/18/2024 Exactech, Inc.
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032... 2 01/18/2024 Exactech, Inc.
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c... 2 01/18/2024 Exactech, Inc.
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d... 2 01/18/2024 Exactech, Inc.
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-0... 2 01/18/2024 Exactech, Inc.
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a ... 2 01/18/2024 Waldemar Link GmbH & Co. KG (Mfg Site)
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm A... 2 12/08/2023 Riverpoint Medical, LLC
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED RE... 2 12/07/2023 Encore Medical, LP
DJO EMPOWR Knee Punch Handle, REF: 801-05-040 2 11/07/2023 Encore Medical, LP
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty 2 11/02/2023 Corin Ltd
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthropla... 2 11/02/2023 Corin Ltd
JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis 2 10/24/2023 Smith & Nephew, Inc.
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis 2 10/24/2023 Smith & Nephew, Inc.
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 2 10/12/2023 Encore Medical, LP
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POC... 2 10/10/2023 Cardinal Health 200, LLC
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece whic... 2 10/06/2023 Zimmer Surgical Inc
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Pr... 2 10/05/2023 Blue Belt Technologies, Inc
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, ... 2 09/20/2023 Smith & Nephew Inc
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 2 09/19/2023 Encore Medical, LP
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a k... 2 08/29/2023 Waldemar Link GmbH & Co. KG (Mfg Site)
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for... 2 08/24/2023 Medtronic Navigation, Inc.-Littleton
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)--... 2 07/20/2023 Materialise N.V.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOIN... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ9... 2 07/12/2023 MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS9855... 2 07/12/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC... 2 07/03/2023 DeRoyal Industries Inc
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intende... 2 07/03/2023 Waldemar Link GmbH & Co. KG (Mfg Site)
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intende... 2 07/03/2023 Waldemar Link GmbH & Co. KG (Mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left 2 06/30/2023 Waldemar Link GmbH & Co. KG (Mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left 2 06/30/2023 Waldemar Link GmbH & Co. KG (Mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right 2 06/30/2023 Waldemar Link GmbH & Co. KG (Mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right 2 06/30/2023 Waldemar Link GmbH & Co. KG (Mfg Site)
Total Knee Pack, REF CETJ130, medical convenience kits 3 06/15/2023 American Contract Systems, Inc.
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hosp... 2 06/07/2023 DeRoyal Industries Inc

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
 
 
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