HRIS Storage & Sterilization Case and Tray — Class II medical device recall Z-2152-2024
Ongoing recall by Howmedica Osteonics Corp., reported 2024-06-26, distributed nationwide. The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument S
| Recall number | Z-2152-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2024-05-23 |
| Classified | 2024-06-18 |
| Reported by FDA | 2024-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CH, CL, DK, ES, GB, HK, IR, IT, JP, KW, MX, NZ, SE, SG, TH, TR |
| Quantity | 630 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 07613327217902 |
| Model numbers | 6210-9-900 |
Product
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Reason for recall
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
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-2152-2024. 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.