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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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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...
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2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Segmental vss bowed 19x190mm, Sterile,
Hip joint, metal/ceramic/polymer, semi-constrained, cemente...
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2
|
03/20/2017
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Zimmer Biomet, Inc.
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Por fullct fem st 15x200mm, Sterile,
prosthesis, hip, semi-constrained, metal/polymer, porous unce...
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2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Por fullct fem st 20x200mm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee,...
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2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Xl por st 24.0x220mm, bowed, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee...
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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.
|
Tibial IM Nail 15mmdx44cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, ...
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2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Fem IM Nail 14mmdx48cm left, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee...
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2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Fem IM Nail 14mmdx48cm right, Sterile,
Rod, fixation, intramedullary and accessories- Specific Kne...
|
2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Fem IM Nail 14mmdx50cm left, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee...
|
2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Fem IM Nail 14mmdx50cm right, Sterile,
Rod, fixation, intramedullary and accessories- Specific Kne...
|
2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Segmental malefemale taper, 200mm, Sterile,
Rod, fixation, intramedullary and accessories- Specifi...
|
2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Segmental malefemale taper, 220mm, Sterile,
Knee joint femorotibial meta/polymer constrained cemen...
|
2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Segmental fluted stem, 17x190mm str, Sterile,
Knee joint femorotibial meta/polymer constrained cem...
|
2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Segmental fluted stem, 18x190mm str, Sterile,
Knee joint femorotibial meta/polymer constrained cem...
|
2
|
03/20/2017
|
Zimmer Biomet, Inc.
|
Knee Scope Pack, part number AMS2498(A
Knee Scope Pack, part number AMS2498(B
Knee Scope Pack, par...
|
2
|
02/28/2017
|
Windstone Medical Packaging, Inc.
|
Knee Pack, part number AMS4211
|
2
|
02/28/2017
|
Windstone Medical Packaging, Inc.
|
Knee Arthroscopy Pack , part number AMS2610(A
Knee Arthroscopy Pack, part number AMS3236(A
Knee Ar...
|
2
|
02/28/2017
|
Windstone Medical Packaging, Inc.
|
Total Knee Pack (15710), part number AMS6563
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2
|
02/28/2017
|
Windstone Medical Packaging, Inc.
|
Oxford Partial Knee System Left Medial Tibial Trial Tray Size D
Product Usage:
Instruments for use...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B
Product Usage:
Instruments ...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B
Product Usage:
Instruments f...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C
Product Usage:
Instruments ...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C
Product Usage:
Instruments f...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D
Product Usage:
Instrument...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Unicompartmental Knee Phase 3 Shim Size 1
Product Usage:
Instruments for use with the Oxfor...
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2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Unicompartmental Knee Phase 3 Shim Size 2
Product Usage:
Instruments for use with the Oxfor...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Unicompartmental Knee Phase 3 Shim Size 3
Product Usage:
Instruments for use with the Oxfor...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Knee System Tibial Resector Body Tube & Guides
Product Usage:
Instruments for use with th...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Femoral Slap Hammer
Product Usage:
Instruments for use with the Oxford ...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Unicompartmental Knee Phase 3 Tibial Impactor
Product Usage:
Instruments for use with the O...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A
Product Usage:
Instrument...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Right Medial Tibial Trial Tray Size F
Product Usage:
Instruments for us...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Left Medial Tibial Trial Tray Size F
Product Usage:
Instruments for use...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Right Medial Tibial Trial Tray Size A
Product Usage:
Instruments for us...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Left Medial Tibial Trial Tray Size A
Product Usage:
Instruments for u...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Right Medial Tibial Trial Tray Size E
Product Usage:
Instruments for us...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Left Medial Tibial Trial Tray Size E
Product Usage:
Instruments for use...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Right Medial Tibial Trial Tray Size D
Product Usage:
Instruments for us...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Right Medial Tibial Trial Tray Size C
Product Usage:
Instruments for us...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Right Medial Tibial Trial Tray Size C
Oxford Partial Knee System Left...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Right Medial Tibial Trial Tray Size B
Product Usage:
Instruments for us...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Oxford Partial Knee System Left Medial Tibial Trial Tray Size B
Product Usage:
Instruments for use...
|
2
|
02/22/2017
|
Biomet U.K., Ltd.
|
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 M...
|
2
|
02/16/2017
|
Zimmer Biomet, Inc.
|
Empowr PS Knee Tibial Insert; Model 343-14-709
The EMPOWR PS tibial insert are made from Highly Cro...
|
2
|
02/03/2017
|
Encore Medical, Lp
|
Vanguard Total Knee System
Vanguard Open Box Femoral Components
Item Number: 183100
Description...
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2
|
01/28/2017
|
Zimmer Biomet, Inc.
|
Orthopedic Salvage System (OSS) 9cm
prosthesis, knee, femorotibial, constrained, cemented, metal/po...
|
2
|
01/28/2017
|
Zimmer Biomet, Inc.
|
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only.
...
|
2
|
01/18/2017
|
Smith & Nephew, Inc.
|
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only.
Intended for patients who w...
|
2
|
01/18/2017
|
Smith & Nephew, Inc.
|
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT
Catalog Number:TPS-111-1111
The iTotal® PS Knee Replac...
|
2
|
01/10/2017
|
ConforMIS, Inc.
|
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is pl...
|
2
|
01/06/2017
|
Zimmer Biomet, Inc.
|
GalaSHAPE 3D; product code SH3D03, a medium size oval
GalaSHAPE" 3D is indicated for use as a biore...
|
2
|
01/05/2017
|
Tepha Incorporated
|
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component ...
|
2
|
12/19/2016
|
Stanmore Implants Worldwide Ltd.
|
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm
The product is a component is a...
|
2
|
12/19/2016
|
Stanmore Implants Worldwide Ltd.
|
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Fe...
|
2
|
12/19/2016
|
Stanmore Implants Worldwide Ltd.
|
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short
The product is a ...
|
2
|
12/19/2016
|
Stanmore Implants Worldwide Ltd.
|
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated ...
|
2
|
12/19/2016
|
Stanmore Implants Worldwide Ltd.
|
Empowr PS Knee System Box Cut Guide
The EMPOWER PS Box Cut Guide is used to make the housing resect...
|
2
|
12/14/2016
|
Encore Medical, Lp
|
Empowr Knee System
Product Usage:
Non-porous proximal tibial baseplate implants, utilized in eit...
|
2
|
12/06/2016
|
Encore Medical, Lp
|
LCS Complete Knee Revision System VVC Insert
Product Usage:
LCS VVC Insert is used in Knee Revis...
|
2
|
12/03/2016
|
DePuy Orthopaedics, Inc.
|
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile
Catalog Number: TCR-111-1...
|
2
|
11/25/2016
|
ConforMIS, Inc.
|
OMNIBotics Tracker Kit -Model: RM-10000
The TOTAL KNEE SURGETICS Navigation System with iBlock (...
|
3
|
11/17/2016
|
OMNI LIFE SCIENCE
|
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posteri...
|
2
|
10/28/2016
|
Encore Medical, Lp
|
Total Knee Pack, Kit number AMS4010(A
convenience custom kits used for general surgery in hospita...
|
2
|
10/20/2016
|
Windstone Medical Packaging, Inc.
|
Knee Scope Pack, Kit number AMS2498 and AMS2498(A
convenience custom kits used for general surgery ...
|
2
|
10/20/2016
|
Windstone Medical Packaging, Inc.
|
Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236,
PSS2188(A, and PSS2208(A
convenience custom kit...
|
2
|
10/20/2016
|
Windstone Medical Packaging, Inc.
|
Knee Pack, Kit number AMS4211
convenience custom kits used for general surgery in hospital operatin...
|
2
|
10/20/2016
|
Windstone Medical Packaging, Inc.
|
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090
Product Usage:
Heavy duty Sagittal Bla...
|
2
|
10/18/2016
|
Stryker Instruments Div. of Stryker Corporation
|
Vanguard Distal Femoral Augment 75 X 5 RL/LM
Product Usage:
Painful and disabled knee joint re...
|
2
|
10/18/2016
|
Zimmer Biomet, Inc.
|
CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only
P...
|
2
|
10/14/2016
|
ConMed Corporation
|
Vanguard 360 Revision Knee System
Knee prostheses
|
2
|
10/03/2016
|
Zimmer Biomet, Inc.
|
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile...
|
2
|
09/20/2016
|
Smith & Nephew, Inc.
|
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 0761332721585...
|
2
|
09/13/2016
|
Stryker Howmedica Osteonics Corp.
|
Femoral Nail, A/R T2 Femur 011x280 mm
T2 Femoral Nailing System is one of the first femoral naili...
|
2
|
09/13/2016
|
Stryker Howmedica Osteonics Corp.
|
Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only
Meshed Integra® Dermal...
|
2
|
09/09/2016
|
Integra LifeSciences Corporation
|
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE...
|
1
|
09/08/2016
|
MicroPort Orthopedics Inc.
|
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE PO...
|
1
|
09/08/2016
|
MicroPort Orthopedics Inc.
|
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE...
|
1
|
09/08/2016
|
MicroPort Orthopedics Inc.
|
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE PO...
|
1
|
09/08/2016
|
MicroPort Orthopedics Inc.
|
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE...
|
1
|
09/08/2016
|
MicroPort Orthopedics Inc.
|
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE PO...
|
1
|
09/08/2016
|
MicroPort Orthopedics Inc.
|
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE...
|
1
|
09/08/2016
|
MicroPort Orthopedics Inc.
|
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE PO...
|
1
|
09/08/2016
|
MicroPort Orthopedics Inc.
|
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE...
|
1
|
09/08/2016
|
MicroPort Orthopedics Inc.
|
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE PO...
|
1
|
09/08/2016
|
MicroPort Orthopedics Inc.
|