🍔 Food 💊 Drugs 🏥 Medical Devices
00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597202017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597202020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597202023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Class II

Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Zimmer, Inc. 20130607 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the country of Japan.
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90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM, Rx, Sterile; 90597002017 Articular Surface CR ART SURF 12/PURPLE 17MM, Rx, Sterile; 90597002020 Articular Surface CR ART SURF 12/PURPLE 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Class II

Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Zimmer, Inc. 20130607 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the country of Japan.
View Details
00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597002017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597002020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597002023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Class II

Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Zimmer, Inc. 20130607 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the country of Japan.
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90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Class II

Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Zimmer, Inc. 20130607 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the country of Japan.
View Details
00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF 1,2/PUR 17, Rx, Sterile; 00595202020 Articular Surface XLPE CR ART SURF 1,2/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Class II

Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Zimmer, Inc. 20130607 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the country of Japan.
View Details
00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Class II

Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Zimmer, Inc. 20130607 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the country of Japan.
View Details
00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Class II

Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Zimmer, Inc. 20130607 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the country of Japan.
View Details
65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile; 65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile; 65597201434 Femur CR POR FEM SURF HDN HATCP DMR, Rx, Sterile; 65597201533 Femur CR POR FEM SURF HDN HATCP EML, Rx, Sterile; 65597201534 Femur CR POR FEM SURF HDN HATCP EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Class II

Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Zimmer, Inc. 20130607 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the country of Japan.
View Details
00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533 Femur CR POR SURF HDN FEM CO-NID EML, Rx, Sterile; 00597201534 Femur CR POR SURF HDN FEM CO-NID EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Class II

Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Zimmer, Inc. 20130607 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the country of Japan.
View Details
00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx, Sterile; 00597201504 Femur CR POR FM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. Class II

Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Zimmer, Inc. 20130607 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the country of Japan.
View Details
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