FDA Device recall Z-2008-2013
65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile
- FDA Device
- Class II
- terminated
- Published 2013-08-28
On 2013-08-28 the FDA classified a Class II recall of 65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile by Zimmer, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2008-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-07 |
| Published | 2013-08-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
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
Identifiers
| code_info | all codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2008-2013%22
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