FDA Device recall Z-1692-2017
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral c…
- FDA Device
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral c… by United Orthopedic, citing the locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1692-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-10 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | United Orthopedic |
| Distribution | CA |
Product
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
Reason
The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
Identifiers
| code_info | Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1692-2017%22
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