Z-2001-2013 Class II Terminated
FDA device recall Z-2001-2013 was initiated by Zimmer, Inc. on Jun 7, 2013 and is designated Class II. 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… The recall status is terminated (terminated Dec 15, 2014). Affected quantity: 192,355.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2013
- Initiation Date
- Jun 7, 2013
- Termination Date
- Dec 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192,355
Product Description
65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP 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
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the country of Japan.
Code Information
all codes
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2001-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026