Drug recall
DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code…
FDA recall event 86713 · Class II · Synthes (USA) Products LLC
Key facts
| Event ID | 86713 |
|---|---|
| Recall numbers | Z-0571-2021, Z-0572-2021, Z-0573-2021, Z-0574-2021, Z-0575-2021, Z-0576-2021, Z-0577-2021, Z-0578-2021, Z-0579-2021, Z-0580-2021, Z-0581-2021, Z-0582-2021 and 5 more |
| Recalling firm | Synthes (USA) Products LLC |
| Product type | Devices |
| Products | DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S, DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S, DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S, DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S, DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S and 12 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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 |
| Initiation date | Nov 19, 2020 |
| Report date | Dec 23, 2020 |
| Termination date | Jul 1, 2022 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3008812560 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: