Device 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.
Z-1692-2017
Product summary
- Event
- Event 76540
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 units
- Official record key
device-enforcement:Z-1692-2017
Official wording
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.
Code information: Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)
Distribution pattern: Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
Derived failure modes
-
Unknown
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.