DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling the 11.5MM Reamer Head for RIA 2, a surgical instrument used in orthopedic procedures. The reamer head has been breaking at a rate higher than expected, particularly when recommended surgical techniques are not followed. This breakage can result in adverse tissue reactions, soft tissue damage, and bone damage to patients during surgery.
The recall affects all lots of this product distributed nationwide in the United States and internationally to multiple countries including the United Kingdom, Germany, Austria, China, Australia, and others. A total of 1,231 units were distributed in the U.S. and 422 units internationally. The source record does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore, Quantity: 1231US; 422 OUS Lot/code info: All Lots UDI: 10886982273970
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.