Zimmer, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2011-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 7, 2013

Date Posted: August 28, 2013

Recall Number: Z-2011-2013

Event ID: 65413

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

Status: Terminated

Product Quantity: 192,355 all devices

Code Information:

all codes

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated