FDA Device recall Z-0396-2013
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS…
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS… by Zimmer, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0396-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2010-10-10 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 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
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
Identifiers
| code_info | All lots distributed from lot 69998600 (2/20/1996) 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-0396-2013%22
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