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U.S. Department of Health and Human Services

Medical Device Recalls

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Product: kne
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Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC... 2 08/09/2016 Stryker Howmedica Osteonics Corp.
Zimmer® Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside o... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged in... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a ... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is package... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II hand... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside o... 2 08/04/2016 Zimmer Surgical Inc
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hing... 2 06/29/2016 Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hin... 2 06/29/2016 Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge... 2 06/29/2016 Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hin... 2 06/29/2016 Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge ... 2 06/29/2016 Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hing... 2 06/29/2016 Smith & Nephew, Inc.
CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot Cinc... 2 05/10/2016 Stryker Corporation
CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot Cinch... 2 05/10/2016 Stryker Corporation
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N ... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 75... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N ... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N ... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 75... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 75... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 75... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 75... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7... 2 04/21/2016 Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N ... 2 04/21/2016 Smith & Nephew, Inc.
Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform ... 2 04/14/2016 Customed, Inc
Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform s... 2 04/14/2016 Customed, Inc
Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical... 2 04/14/2016 Customed, Inc
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm St... 2 04/06/2016 Zimmer Manufacturing B.V.
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm St... 2 04/06/2016 Zimmer Manufacturing B.V.
All instrumentation associated with the Prelude PF Resurfacing Knee System. 2 04/04/2016 Biomet, Inc.
Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide ... 2 03/31/2016 Ossur H / F
Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for... 2 03/31/2016 Ossur H / F
Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that ... 2 03/31/2016 Ossur H / F
Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides suppo... 2 03/31/2016 Ossur H / F
Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort unde... 2 03/31/2016 Ossur H / F
Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the k... 2 03/31/2016 Ossur H / F
Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for k... 2 03/31/2016 Ossur H / F
Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for... 2 03/31/2016 Ossur H / F
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replac... 2 03/25/2016 Biomet, Inc.
Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEX... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NE... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NE... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NE... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NE... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MG... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MA... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/... 2 03/12/2016 Zimmer Manufacturing B.V.
Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501... 2 03/12/2016 Zimmer Manufacturing B.V.
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee Syst... 2 03/03/2016 Aesculap, Inc.
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compa... 2 03/01/2016 Mako Surgical Corporation
NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, pate... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibi... 2 02/22/2016 Zimmer Biomet, Inc.
CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, ... 2 02/22/2016 Zimmer Biomet, Inc.
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, ... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibi... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-c... 2 02/22/2016 Zimmer Biomet, Inc.
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile ... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Po... 2 02/22/2016 Zimmer Biomet, Inc.
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/... 2 02/22/2016 Zimmer Biomet, Inc.
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, por... 2 02/22/2016 Zimmer Biomet, Inc.
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Fl... 2 02/22/2016 Zimmer Biomet, Inc.
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, ... 2 02/22/2016 Zimmer Biomet, Inc.
LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL;... 2 02/17/2016 Smith & Nephew, Inc.
SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the ti... 2 02/09/2016 DePuy Orthopaedics, Inc.
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prostheti... 2 02/01/2016 Otto Bock Healthcare GmbH
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugment... 2 01/05/2016 Zimmer Manufacturing B.V.
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR C... 2 01/04/2016 Smith & Nephew, Inc.
HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicat... 2 01/04/2016 Corflex
ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee Brace is i... 2 01/04/2016 Corflex
ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indica... 2 01/04/2016 Corflex
CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated f... 2 01/04/2016 Corflex
CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indi... 2 01/04/2016 Corflex
Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicate... 2 01/04/2016 Corflex
BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is ... 2 01/04/2016 Corflex
Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibia... 2 12/18/2015 Zimmer Manufacturing B.V.
Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, i... 2 12/10/2015 Zimmer, Inc.
Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis... 2 12/10/2015 Zimmer, Inc.
Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a componen... 2 12/02/2015 Stryker Howmedica Osteonics Corp.
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-... 2 11/19/2015 TZ Medical Inc.
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery 2 11/14/2015 Medacta Usa
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot Admi... 2 11/09/2015 Stryker Howmedica Osteonics Corp.
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630... 2 11/06/2015 DeRoyal Industries Inc
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (co... 2 11/05/2015 Mako Surgical Corporation
Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee S... 2 10/26/2015 Encore Medical, Lp
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surg... 2 10/23/2015 Materialise N.V.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 ... 2 10/22/2015 Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 ... 2 10/22/2015 Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 ... 2 10/22/2015 Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 ... 2 10/22/2015 Smith & Nephew, Inc., Endoscopy Div.

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