FDA (Devices) recall action 73142

Zimmer Biomet, Inc. recalled 21 products on 2016-03-02

The FDA (Devices) publishes a recall like this one as 21 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 21 pages.

Products: 21
Announced: 2016-03-02
Critical: 0
Units: 738,203

Why these products were recalled

LDPE bag containing the implant adheres to the highly polished implant surface.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–21 of 21

ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Versus Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 1,305 Versus 6-inch hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascula
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0 states
LowFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Issue
Zimmer Biomet is recalling CR Flex and LPS Flex knee prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes This device is indicated for patients with severe knee pain and disability
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ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 101 Versus 7.5 inch hip prostheses because the LDPE packaging bag adheres to the implant surface.
Product
VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascula
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0 states
ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Metasul Head 40 Total Hip Prosthesis Components
Zimmer Biomet is recalling 194 Metasul Head 40 total hip prosthesis components because the packaging bag adheres to the implant surface.
Product
Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid
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0 states
ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls CPT Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 289 CPT 12/14 COCR hip prostheses because the LDPE packaging bag adheres to the implant surface.
Product
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, poly
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0 states
ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Versus 6 Inch Beaded FC 1 Hip Prosthesis
Zimmer Biomet is recalling 130 units of Versus 6 Inch Beaded FC 1 hip prostheses because the packaging bag adheres to the implant surface.
Product
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascula
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Defect
Zimmer Biomet is recalling specific CR Flex and Natural Knee prosthesis components because the LDPE packaging bag adheres to the polished implant surface.
Product
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are indi
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ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion Issue
Zimmer Biomet is recalling NexGen Knee femoral prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes This device is indicated for patient
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0 states
ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 4,844 Versys hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthriti
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0 states
ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion
Zimmer Biomet is recalling NexGen Knee LPS and Lock femoral components because the LDPE packaging bag adheres to the polished implant surface.
Product
NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due t
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ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Knee Prosthesis Due to Packaging Adhesion Issue
Zimmer Biomet is recalling Zimmer Uni High Flex Precoat Femoral knee prostheses because the LDPE packaging bag adheres to the implant surface.
Product
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyl
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ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls NexGen LPS Flex Femoral Knee Implants
Zimmer Biomet is recalling NexGen LPS Flex femoral knee implants because the packaging bag adheres to the polished implant surface.
Product
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, os
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0 states
ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls CPT Hip Prostheses Due to Packaging Adhesion Issue
Zimmer Biomet is recalling CPT 12/14 COCR hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, pol
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0 states
ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls NexGen LPS-FLEX Femoral Knee Implants
Zimmer Biomet is recalling NexGen LPS-FLEX femoral knee implants because the packaging bag adheres to the polished implant surface.
Product
NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumato
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0 states
LowFDA (Devices)··2016-03-02
Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion
Zimmer Biomet is recalling NexGen Knee CR femoral components because the packaging bag adheres to the implant surface.
Product
NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthr
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ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls NexGen CR-FLEX Knee Implants Due to Packaging Defect
Zimmer Biomet is recalling NexGen CR-FLEX knee prostheses because the LDPE packaging bag adheres to the implant surface. The recall covers 42,064 units distributed worldwide.
Product
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheum
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ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Natural-Knee II Femoral Prostheses Due to Packaging Defect
Zimmer Biomet is recalling 13,483 Natural-Knee II femoral prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or
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ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Bipolar Shell Hip Prostheses Due to Packaging Defect
Zimmer Biomet is recalling 72,806 Bipolar Shell hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bipolar Cup is indicated in: Fracture dislocation of the hip. Elderly, debilitated patients when a total hip replacement is contra
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ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Defect
Zimmer Biomet is recalling 4,567 knee prosthesis units because the LDPE packaging bag adheres to the polished implant surface.
Product
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthriti
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ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls LPS-FLEX GSF OPT Knee Prostheses Due to Packaging Defect
Zimmer Biomet is recalling LPS-FLEX GSF OPT knee prostheses because the LDPE bag adheres to the implant surface. The recall covers 84,396 units distributed worldwide.
Product
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthr
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ModerateFDA (Devices)··2016-03-02
Zimmer Biomet Recalls Gender PFJ Femoral Components Due to Packaging Defect
Zimmer Biomet is recalling 5,103 Gender PFJ Femoral Components because the LDPE packaging bag adheres to the implant surface. The device is distributed worldwide.
Product
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage
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