FEM COND BUTTRESS PLT — Class II medical device recall Z-0591-2014
Terminated recall by Zimmer, Inc., reported 2014-01-08. Based on a review of historic packaging validations, it was determined that a subset of product packaged at a
| Recall number | Z-0591-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-11-05 |
| Classified | 2013-12-27 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2015-05-05 |
| Reason classes | sterility |
| Model numbers | 00-2347-002-12, 00-2347-002-14, 00-2347-002-16, 00-2347-002-18 |
Product
FEM COND BUTTRESS PLT, LT
Reason for recall
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
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-0591-2014. 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.