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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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CR-FLEX GSF PCT SZ C-R MINUS® CR-FLEX GSF PCT SZ D-L MINUS® CR-FLEX GSF PCT SZ D-R MINUS® CR-FLEX... 2 03/14/2018 Zimmer Biomet, Inc.
NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT® " These devices are indicated for patients with... 2 03/14/2018 Zimmer Biomet, Inc.
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM ... 2 03/14/2018 Zimmer Biomet, Inc.
ZUK PRC FEM SZB RMED/LLAT® ZUK PRC FEM SZC LMED/RLAT® ZUK PRC FEM SZC RMED/LLAT® NGU PRC FEM SZD ... 2 03/14/2018 Zimmer Biomet, Inc.
PRCT MIS CR MOB PLT SZ 4 L® PRCT MIS CR MOB PLT SZ 5 L® PRCT MIS CR MOB PLT SZ 6 L® PRCT MIS CR M... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM ... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for ... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM ... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L... 2 03/14/2018 Zimmer Biomet, Inc.
NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee ... 2 03/14/2018 Zimmer Biomet, Inc.
LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX P... 2 03/14/2018 Zimmer Biomet, Inc.
LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTI... 2 03/14/2018 Zimmer Biomet, Inc.
CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM... 2 03/14/2018 Zimmer Biomet, Inc.
CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT... 2 03/14/2018 Zimmer Biomet, Inc.
LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is ind... 2 03/14/2018 Zimmer Biomet, Inc.
LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS ... 2 03/14/2018 Zimmer Biomet, Inc.
LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patien... 2 03/14/2018 Zimmer Biomet, Inc.
LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L ... 2 03/14/2018 Zimmer Biomet, Inc.
O-arm® O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Ima... 2 03/08/2018 Medtronic Navigation, Inc.-Littleton
OTTO BOCK Kenevo knee joints Model 3C60 2 03/01/2018 Otto Bock Healthcare Product
OTTO BOCK Kenevo knee joints Model 3C60=ST 2 03/01/2018 Otto Bock Healthcare Product
AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02 2 02/28/2018 Avid Medical, Inc.
The 2nd Assist Knee Positioner 2 02/28/2018 Zimmer Biomet, Inc.
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED ... 2 02/26/2018 Zimmer Biomet, Inc.
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201)... 2 02/26/2018 Zimmer Biomet, Inc.
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joi... 2 02/21/2018 ZIMMER ORTHOPEDIC MFG LTD
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Pr... 2 02/21/2018 Zimmer Biomet, Inc.
Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product U... 2 02/21/2018 Zimmer Biomet, Inc.
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The fir... 2 02/16/2018 Oculus Optikgeraete GMBH
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For... 2 02/15/2018 Zimmer Biomet, Inc.
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For ... 2 02/15/2018 Zimmer Biomet, Inc.
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used ... 2 02/14/2018 Zimmer Biomet, Inc.
Synvisc-One ® (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous h... 2 02/14/2018 Sanofi Genzyme
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- an... 2 02/13/2018 ConforMIS, Inc.
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST046... 2 02/12/2018 Aesculap Implant Systems LLC
Persona Partial Knee System, Size 8, Finishing Guide 2 01/14/2018 Zimmer Biomet, Inc.
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Contai... 2 01/12/2018 DeRoyal Industries Inc
EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in ortho... 2 01/10/2018 Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthope... 2 01/10/2018 Encore Medical, Lp
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthope... 2 01/10/2018 Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthop... 2 01/10/2018 Encore Medical, Lp
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Gala... 2 12/27/2017 Orthofix Srl
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inser... 2 12/20/2017 Medacta Usa Inc
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STE... 2 11/16/2017 Smith & Nephew, Inc.
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONL... 2 11/16/2017 Arthrex, Inc.
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intend... 2 11/08/2017 Zimmer Biomet, Inc.
Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV... 2 11/06/2017 Encore Medical, Lp
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV... 2 11/06/2017 Encore Medical, Lp
Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOME... 2 11/06/2017 Encore Medical, Lp
Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOME... 2 11/06/2017 Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage Th... 2 10/20/2017 Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EM... 2 10/20/2017 Encore Medical, Lp
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic ... 2 09/13/2017 Mako Surgical Corporation
Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system c... 2 08/11/2017 Exactech, Inc.
3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert... 2 06/30/2017 Encore Medical, Lp
3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert ... 2 06/30/2017 Encore Medical, Lp
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). ... 2 05/30/2017 KCI USA, INC.
Reusable instruments in the Knee, Hip, Trauma, and Extremities segments. 2 05/22/2017 Zimmer Biomet, Inc.
Navitrack System - OS Knee Universal, Stereotaxic instrument 2 05/12/2017 Orthosoft, Inc. dba Zimmer CAS
Navitrack® System - OS Knee Universal, Orthopedic Stereotaxic Instrument 3 05/12/2017 Orthosoft, Inc. dba Zimmer CAS
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an in... 2 05/02/2017 Breg Inc
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an in... 2 05/02/2017 Breg Inc
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application in... 2 04/26/2017 Orthosoft, Inc. dba Zimmer CAS
Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATEL... 2 04/25/2017 Zimmer Biomet, Inc.
SmartTools Knee System Orthopedic Stereotaxic Instrument 2 04/19/2017 Orthosoft, Inc. dba Zimmer CAS
Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps 2 04/12/2017 2k Innovations Inc.
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic... 2 03/27/2017 Zimmer Biomet, Inc.
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial ... 2 03/27/2017 Zimmer Biomet, Inc.
Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa 2 03/24/2017 Resource Optimization & Innovation Llc
Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa 2 03/24/2017 Resource Optimization & Innovation Llc
Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa 2 03/24/2017 Resource Optimization & Innovation Llc
Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU 2 03/24/2017 Resource Optimization & Innovation Llc
Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU 2 03/24/2017 Resource Optimization & Innovation Llc
Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component... 2 03/21/2017 Medtronic Sofamor Danek USA Inc
Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Tria... 2 03/21/2017 Medtronic Sofamor Danek USA Inc
Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component T... 2 03/21/2017 Medtronic Sofamor Danek USA Inc
Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component T... 2 03/21/2017 Medtronic Sofamor Danek USA Inc
Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cem... 2 03/20/2017 Zimmer Biomet, Inc.
Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cem... 2 03/20/2017 Zimmer Biomet, Inc.
Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cem... 2 03/20/2017 Zimmer Biomet, Inc.
Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cem... 2 03/20/2017 Zimmer Biomet, Inc.
Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Speci... 2 03/20/2017 Zimmer Biomet, Inc.
Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemente... 2 03/20/2017 Zimmer Biomet, Inc.
Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous unce... 2 03/20/2017 Zimmer Biomet, Inc.
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee,... 2 03/20/2017 Zimmer Biomet, Inc.
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee... 2 03/20/2017 Zimmer Biomet, Inc.
Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Speci... 2 03/20/2017 Zimmer Biomet, Inc.
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee,... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.
Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip... 2 03/20/2017 Zimmer Biomet, Inc.

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