00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26 — Class II medical device recall Z-2037-2013

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-2037-2013`
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

00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, 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-2037-2013. 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.