Unity CR Femur Right — Class II medical device recall Z-0213-2024
Ongoing recall by Corin Ltd, reported 2023-11-08, distributed in IL, MI, TX. Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts R
| Recall number | Z-0213-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Corin Ltd, Cirencester, N/A, United Kingdom |
| Recall initiated | 2023-10-13 |
| Classified | 2023-11-02 |
| Reported by FDA | 2023-11-08 |
| Distributed | IL, MI, TX |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 05055343872499 |
| Lot numbers | 529803 |
| Model numbers | 112.001.32 |
Product
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
Reason for recall
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
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-0213-2024. 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.