00789504001 VerSys Femoral Head Provisional 40mm -3 — Class II medical device recall Z-0394-2013
Terminated recall by Zimmer, Inc., reported 2012-11-28, distributed nationwide. Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inf
| Recall number | Z-0394-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2010-10-10 |
| Classified | 2012-11-19 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2014-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, CA, MX |
| Quantity | 128,946 all |
| Lot numbers | 69998600 |
Product
00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty
Reason for recall
Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. To reduce incidence of sub-optimal fit between provisional femoral heads and the mat
Machine access
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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.