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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- United Orthopedic Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)
Distribution:
Distributed in: US, CA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1692-2017
Related Recalls
Their is a potential that the implant curved stem may be oriented incorrectly.
Their is a potential that the implant curved stem may be oriented incorrectly.
Their is a potential that the implant curved stem may be oriented incorrectly.