Reported Apr 5, 2017 · Terminated
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery…
United Orthopedic Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: United Orthopedic Corporation · No. 57 Park Avenue 2, Science Park · Hsinchu · N/A
Is this the product you have?
- 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.
- Lot codes and dates
Lot numbers T16A178A (17 units)T16A178B (1 unit)T16A178B1 (3 units)T16A178C (12 units)
- Amount recalled
- 33 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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