90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17 — Class II medical device recall Z-2023-2013
Terminated recall by Zimmer, Inc., reported 2013-08-28, distributed nationwide. Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations
| Recall number | Z-2023-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-06-07 |
| Classified | 2013-08-22 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-12-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 192,355 all |
| Reason classes | labeling, unapproved product |
Product
90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; 90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 20, 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2023-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.