PlainRecalls
FDA Devices Moderate Class II Terminated

65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Reported: August 28, 2013 Initiated: June 7, 2013 #Z-2003-2013

Product Description

65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Reason for Recall

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

Details

Recalling Firm
Zimmer, Inc.
Units Affected
192,355 all devices
Distribution
Worldwide Distribution-USA (nationwide) and the country of Japan.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.. Recalled by Zimmer, Inc.. Units affected: 192,355 all devices.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2013. Severity: Moderate. Recall number: Z-2003-2013.

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