OP7543 Design Y Mandible Onlay — Class II medical device recall Z-1382-2017
Terminated recall by Matrix Surgical Holdings, LLC, reported 2017-03-08. Mislabeling. The packaging labeled as left mandible contained a right mandible.
| Recall number | Z-1382-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Matrix Surgical Holdings, LLC, Atlanta, GA, United States |
| Recall initiated | 2017-01-25 |
| Classified | 2017-02-28 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2017-05-24 |
| Countries outside the US | BR, CL, CO, NO, SA, SE, TW, ZA |
| Quantity | 28 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00855421005666, 00855421005673 |
| Lot numbers | 01211086, 013110816 |
Product
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Reason for recall
Mislabeling. The packaging labeled as left mandible contained a right mandible.
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-1382-2017. 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.