00780303201 MIS 12/14 Slotted Femoral Head Provisional -3 — Class II medical device recall Z-0398-2013
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-0398-2013 |
|---|---|
| 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 | 56,516 all |
| Lot numbers | 69998600 |
Product
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 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.