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U.S. Department of Health and Human Services

Medical Device Recalls
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LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14 2 05/04/2023 Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15 2 05/04/2023 Linkbio Corp.
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/... 2 04/25/2023 ROi CPS LLC
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108 2 04/12/2023 Encore Medical, LP
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial ... 2 04/12/2023 Howmedica Osteonics Corp.
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial ... 2 04/12/2023 Howmedica Osteonics Corp.
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7,... 2 02/27/2023 Encore Medical, LP
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PA... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. O... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. ... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY ... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement pros... 2 01/30/2023 Biomet, Inc.
(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement pro... 2 01/30/2023 Biomet, Inc.
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case 2 01/27/2023 MEDLINE INDUSTRIES, LP - Northfield
Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case 2 01/27/2023 MEDLINE INDUSTRIES, LP - Northfield
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement... 2 01/27/2023 Biomet, Inc.
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint... 2 01/26/2023 Biomet, Inc.
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M C... 2 01/04/2023 Windstone Medical Packaging, Inc.
DeRoyal TOTAL KNEE PACK, REF 89-9300.08 2 12/15/2022 DeRoyal Industries Inc
GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02 2 12/15/2022 DeRoyal Industries Inc
GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09 2 12/15/2022 DeRoyal Industries Inc
GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13 2 12/15/2022 DeRoyal Industries Inc
GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07 2 12/15/2022 DeRoyal Industries Inc
DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02 2 12/15/2022 DeRoyal Industries Inc
HENRY SCHEIN, Knee Pack, Item No.570-2908, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base 2 11/22/2022 MicroPort Orthopedics Inc.
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base 2 11/22/2022 MicroPort Orthopedics Inc.
Unity Total Knee System. Used for knee prosthesis in total knee replacement 2 11/21/2022 Corin Ltd
Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various ty... 2 11/08/2022 Beaver Visitec International, Inc.
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. 2 10/21/2022 Encore Medical, LP
OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L ... 2 09/28/2022 Ossur Americas
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. 2 09/23/2022 Howmedica Osteonics Corp.
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. in... 2 07/15/2022 Aesculap Implant Systems LLC
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 2 06/09/2022 Encore Medical, LP
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack 2 05/06/2022 American Contract Systems, Inc.
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic ma... 2 04/29/2022 restor3d Inc.
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual ... 2 04/29/2022 restor3d Inc.
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 2 04/08/2022 Conformis, Inc.
Total Knee Pack - Surgical Kit 2 04/04/2022 Stradis Medical, LLC dba Stradis Healthcare
NavitrackER Kit A: Knee, Model Number 20-8000-000-07, 2 03/03/2022 Orthosoft, Inc. dba Zimmer CAS
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty ... 2 02/09/2022 DePuy Orthopaedics, Inc.
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthropl... 2 02/09/2022 DePuy Orthopaedics, Inc.
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in prep... 2 01/06/2022 Howmedica Osteonics Corp.
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Cat... 2 10/14/2021 Uoc Usa Inc
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:15230700... 2 10/07/2021 DePuy Orthopaedics, Inc.
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULI... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK A... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Informati... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: ... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Produc... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Ti... 2 10/04/2021 Exactech, Inc.
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Steri... 2 09/30/2021 Corin Ltd
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile... 2 09/30/2021 Corin Ltd
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a com... 2 09/30/2021 Corin Ltd
Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL C... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMU... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBI... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL C... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL C... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL C... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL C... 2 09/22/2021 Aesculap Implant Systems LLC
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 151... 2 08/25/2021 DePuy Orthopaedics, Inc.
Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3... 2 08/09/2021 Medline Industries Inc
Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irri... 2 08/09/2021 Medline Industries Inc
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Steri... 2 07/20/2021 Encore Medical, LP
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Steri... 2 07/20/2021 Encore Medical, LP
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral... 2 06/24/2021 Smith & Nephew, Inc.
DJO EMPOWR KNEE Femoral Sizer 2 04/30/2021 Encore Medical, LP
INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides ... 2 04/27/2021 ConMed Corporation
KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides... 2 04/27/2021 ConMed Corporation
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System,... 2 04/09/2021 Howmedica Osteonics Corp.
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of th... 2 03/29/2021 DePuy Orthopaedics, Inc.
ATTUNE® FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and p... 2 03/29/2021 DePuy Orthopaedics, Inc.
The ATTUNE® Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple component... 2 03/29/2021 DePuy Orthopaedics, Inc.
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/... 2 03/08/2021 Howmedica Osteonics Corp.
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noile... 2 02/09/2021 DePuy Orthopaedics, Inc.
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Prod... 2 01/29/2021 Smith & Nephew, Inc.
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, I... 2 12/28/2020 ROi CPS LLC
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee a... 2 12/23/2020 Biomet, Inc.
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligam... 2 12/21/2020 ConMed Corporation
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligam... 2 12/21/2020 ConMed Corporation
RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Pr... 2 12/17/2020 Biomet, Inc.

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