Simplex HV With Gentamicin CE — Class II medical device recall Z-0240-2023
Ongoing recall by Howmedica Osteonics Corp., reported 2022-11-23, distributed nationwide. Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex
| Recall number | Z-0240-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2022-10-21 |
| Classified | 2022-11-15 |
| Reported by FDA | 2022-11-23 |
| Distributed | Nationwide (US) |
| Quantity | 90 units |
| UPC / GTIN / UDI-DI | 14260056885768 |
| Lot numbers | 202BB943KC, 30/SEP/2024 |
| Model numbers | 6193-1-010 |
Product
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
Reason for recall
Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)
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-0240-2023. 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.