INBONE Total Ankle System — Class II medical device recall Z-0315-2022
Terminated recall by Wright Medical Technology Inc, reported 2021-12-08, distributed nationwide. The package contents and package labeling do not match.
| Recall number | Z-0315-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wright Medical Technology Inc, Arlington, TN, United States |
| Recall initiated | 2021-11-04 |
| Classified | 2021-12-01 |
| Reported by FDA | 2021-12-08 |
| Terminated | 2023-01-06 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00840420124968 |
| Lot numbers | 05113580751661825 |
| Model numbers | 220222210E |
Product
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Reason for recall
The package contents and package labeling do not match.
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-0315-2022. 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.