Z-2255-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2014
- Initiation Date
- July 11, 2014
- Termination Date
- October 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
Code Information
PS Tibial Insert Size 3 8mm,Part 163-1308,Lot A135943,PS Tibial Insert Size 3 9mm,Part 163-1309,Lot A136492,PS Tibial Insert Size 3 12mm,Part 163-1312,Lot A136453,PS Tibial Insert Size 4 7mm,Part 163-1407,Lot A135945,PS Tibial Insert Size 4 7mm,Part 163-1407,Lot A136454,PS Tibial Insert Size 5 9mm,Part 163-1509,Lot A135827,