RIA Tube Assembly — Class II medical device recall Z-1237-2024
Ongoing recall by Synthes (USA) Products LLC, reported 2024-03-13, distributed nationwide. Products not sterilized, sterility cannot be confirmed
| Recall number | Z-1237-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2024-01-24 |
| Classified | 2024-03-01 |
| Reported by FDA | 2024-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CZ, DE, ES, FI, FR, GB, IE, KR, KW, MX, NL, SK, TW, ZA |
| Quantity | 144 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10886982189080 |
| Lot numbers | H802995, H803000, H803020, H830033 |
| Model numbers | 314.746S |
Product
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis. Part Number: 314.746S
Reason for recall
Products not sterilized, sterility cannot be confirmed
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-1237-2024. 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.