00780304001 MIS 12/14 Slotted Femoral Head Provisional -3 — Class II medical device recall Z-2484-2012
Terminated recall by Zimmer, Inc., reported 2012-10-10, distributed nationwide. Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and
| Recall number | Z-2484-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2011-04-01 |
| Classified | 2012-09-28 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2014-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, KR, MX |
| Quantity | 231,641 all |
| Lot numbers | 78939000 |
Product
00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 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
Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp
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.