Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation… — Class III medical device recall Z-0737-2023
Ongoing recall by Howmedica Osteonics Corp., reported 2022-12-28. Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Althoug
| Recall number | Z-0737-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2022-11-07 |
| Classified | 2022-12-20 |
| Reported by FDA | 2022-12-28 |
| Countries outside the US | TR |
| Quantity | 20 units |
| UPC / GTIN / UDI-DI | 07613327128741 |
| Model numbers | 6197-1-001 |
Product
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Reason for recall
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
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-0737-2023. 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.