medical Class II Updated 2020-12-23

Synthes (USA) Products LLC recalls DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedi

Recalled Product

DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots UDI: 10886982273970
View official government recall

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