FDAFDA · Food and drugs·Recall number Z-2256-2014
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
Published August 27, 2014 · Recall initiated: July 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Ortho Development Corporation
- Distributor
- Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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