FDA Device recall Z-2255-2014
PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation…
- FDA Device
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation… by Ortho Development, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2255-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-11 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Development |
| Distribution | US |
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
Reason
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.
Identifiers
| 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…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2255-2014%22
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