FDANovember 19, 2020device
DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
synthes usa productssynthessynthes usa
UPCs
10886982273949
Recall history
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