FDA Device recall Z-2038-2013
00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile
- FDA Device
- Class II
- terminated
- Published 2013-08-28
On 2013-08-28 the FDA classified a Class II recall of 00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, 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-2038-2013 |
| 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
00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile; 00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Sterile; 00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM, 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-2038-2013%22
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