Tibial Tray Nonporous A Size 2 — Class II medical device recall Z-1903-2020
Ongoing recall by Ortho Development Corporation, reported 2020-05-13, distributed in CA, FL, OH, PA, TX, UT. The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut alo
| Recall number | Z-1903-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Development Corporation, Draper, UT, United States |
| Recall initiated | 2019-05-30 |
| Classified | 2020-05-05 |
| Reported by FDA | 2020-05-13 |
| Distributed | CA, FL, OH, PA, TX, UT |
| Countries outside the US | JP |
| Quantity | 27 |
| Lot numbers | A200590 |
| Model numbers | 162-1200-A |
Product
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Reason for recall
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.
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-1903-2020. 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.