VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW — Class II medical device recall Z-2092-2013
Terminated recall by Zimmer, Inc., reported 2013-09-04, distributed nationwide. Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromis
| Recall number | Z-2092-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-06-19 |
| Classified | 2013-08-26 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2015-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CH, CN, DE, EG, ES, FR, GB, HN, IL, IQ, IR, IT, JO, KR, LB, MX, SA |
| Reason classes | sterility, packaging |
Product
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
Reason for recall
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
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-2092-2013. 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.