FDA Device recall Z-2482-2012
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS…
- FDA Device
- Class II
- terminated
- Published 2012-10-10
On 2012-10-10 the FDA classified a Class II recall of 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS… by Zimmer, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2482-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-04-01 |
| Published | 2012-10-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
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
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
Identifiers
| code_info | All lots including lot 78939000 (1/7/2002) to present |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2482-2012%22
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