Recall Z-1692-2017— United Orthopedic Corporation
Class II · Terminated
Class II FDA medical device recall by United Orthopedic Corporation, initiated 2017-02-10, terminated 2017-06-28. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- United Orthopedic Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-10
- Terminated
- 2017-06-28
- Firm location
- Hsinchu, Taiwan
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.