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.
This recall has been terminated (originally issued March 1, 2017).
- Recall Initiated
- February 10, 2017
- Posted
- March 1, 2017
- Terminated
- June 28, 2017
- Recall Number
- Z-1692-2017
- Quantity
- 33 units
- Firm Location
- Science Park Hsinchu Taiwan
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
Lot / Code Info
Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)
Root Cause
Device Design
Action Taken
United Orthopedic Corporation sent an Urgent Field Safety Notice dated January 19, 2017, to all affected consignees via e-mail on February 10. 2017. The Urgent Field Safety Notice instructed consignees to recover any affected units and return them to the manufacturer. A redesigned device will be sent for replacements. Consignees with questions were instructed to call 949-328-3366.