Class II — Ortho Development Corporation
| Recalling firm | Ortho Development Corporation |
|---|---|
| Registered facility | ORTHO DEVELOPMENT CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component |
| Quantity | 14 |
| Distribution | Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees. |
| Initiated | 2014-07-11 |
| Classified | 2014-08-17 |
| Terminated | 2014-10-06 |
| Recall number | Z-2254-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ortho Development Corporation (Z-2254-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68898/
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