Device product
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Z-0574-2021
Product summary
- Event
- Event 86713
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1231US; 422 OUS
- Official record key
device-enforcement:Z-0574-2021
Official wording
Reason: 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
Code information: All Lots UDI: 10886982273970
Distribution pattern: Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
Derived failure modes
-
Unknown
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