Recall Z-2255-2014
Ortho Development Corporation · initiated July 11, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: 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,
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.
FDA-determined 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.
Details
- Recall number
- Z-2255-2014
- Initiated
- July 11, 2014
- Posted by FDA
- August 17, 2014
- Terminated
- October 6, 2014
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 11
- Distribution
- Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
- Recalling firm
- Ortho Development Corporation, Draper, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2253-2014 Class II | Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a…Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and… | 07/11/2014Terminated |
| Z-2254-2014 Class II | Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to…Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and… | 07/11/2014Terminated |
| Z-2256-2014 Class II | Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used…Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and… | 07/11/2014Terminated |
| Z-2257-2014 Class II | Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE…Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and… | 07/11/2014Terminated |