DePuy Synthes 16 — Class II medical device recall Z-0584-2021
Terminated recall by Synthes (USA) Products LLC, reported 2020-12-23, distributed nationwide. RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tis
| Recall number | Z-0584-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2020-11-19 |
| Classified | 2020-12-15 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2022-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CH, CN, CZ, DE, ES, GB, IE, IL, IT, SG |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10886982274038 |
| Model numbers | 03.404.029S |
Product
DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
Reason for recall
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
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-0584-2021. 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.