DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
Check against the official notice below — it lists the full affected range.
DePuy Synthes (USA) Products LLC is recalling the 16.5MM REAMER HEAD FOR RIA 2 STERILE, an orthopedic manual surgical instrument (Part Code: 03.404.029S). The recall affects 531 units in the United States and 317 units distributed to other countries including the United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, the United Kingdom, Ireland, Israel, Italy, and Singapore. All lots of this product are included in the recall.
The reamer head has been found to break at rates higher than expected when recommended surgical techniques are not followed, potentially causing adverse tissue reactions, soft tissue damage, and bone damage. The source document does not specify what remedy or corrective action affected consumers should take.
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: 531 US; 317 OUS Lot/code info: All Lots UDI: 10886982274038
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.