PS Tibial Insert — Class II medical device recall Z-2255-2014
Terminated recall by Ortho Development Corporation, reported 2014-08-27, distributed nationwide. Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK
| Recall number | Z-2255-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Development Corporation, Draper, UT, United States |
| Recall initiated | 2014-07-11 |
| Classified | 2014-08-17 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2014-10-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 11 |
| Reason classes | packaging |
| Lot numbers | A135827, A135943, A135945, A136453, A136454, A136492 |
| Model numbers | 163-1308, 163-1309, 163-1312, 163-1407, 163-1509, 163-1XXX |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2255-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.