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
- Company
- Ortho Development Corporation
- Recall Initiated
- July 11, 2014
- Posted
- August 17, 2014
- Terminated
- October 6, 2014
- Recall Number
- Z-2255-2014
- Quantity
- 11
- Firm Location
- Draper, UT
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
Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
Lot / Code Info
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,
Root Cause
Packaging process control
Action Taken
Ortho Development notified all affected consignees/distributors of the recall via email on July 11, 2014 which included a list of the affected product (part numbers, lot numbers and quantities) under their control. An RMA number and return shipping label were also included with the email. Emails were followed up with phone calls to verify receipt of the notification.