Tibial Opening Wedge Osteotomy Plate — Class II medical device recall Z-1380-2021
Terminated recall by Arthrex, Inc., reported 2021-04-21, distributed nationwide. It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
| Recall number | Z-1380-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2021-03-11 |
| Classified | 2021-04-09 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2024-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BH, CA, IN, IT, MX, NZ, PL, RU, SE |
| Quantity | 32 units |
| Lot numbers | 12135408 |
| Model numbers | AR-13200T-15.0 |
Product
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Reason for recall
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
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-1380-2021. 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.