Z-1692-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- February 10, 2017
- Termination Date
- June 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 units
Product Description
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 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 Pattern
Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
Code Information
Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)