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 | Ongoing |
| Reason | The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled. |
| Product | Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V. |
| Quantity | 29 |
| Distribution | US: CA, FL, OH, PA, TX, and UT. OUS: Japan. |
| Initiated | 2019-05-30 |
| Classified | 2020-05-05 |
| Recall number | Z-1904-2020 |
| 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-1904-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85157/
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