Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
Class I - DangerousWhat Should You Do?
- Check if you have this product: UC Tibial Insert Sz 3 10mm,Part 163-3310,Lot A136109,UC Tibial Insert Sz 4 8mm,Part 163-3408,Lot A135948,UC Tibial Insert Sz 4 14mm,Part 163-3414,Lot A136110,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136113,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136746,
- 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:
- Ortho Development Corporation
- Reason for Recall:
- Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
Product Codes/Lot Numbers:
UC Tibial Insert Sz 3 10mm,Part 163-3310,Lot A136109,UC Tibial Insert Sz 4 8mm,Part 163-3408,Lot A135948,UC Tibial Insert Sz 4 14mm,Part 163-3414,Lot A136110,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136113,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136746,
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2256-2014
Related Recalls
The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.
Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
Ortho Development
The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.
Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.