DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling the 13.5MM Reamer Head for RIA 2, a sterile orthopedic manual surgical instrument (Part Code: 03.404.023S). The reamer head is breaking at rates higher than expected, which can cause adverse tissue reactions, soft tissue damage, and bone damage when recommended surgical techniques are not followed. A total of 1,262 units were distributed in the United States and 549 units overseas across countries including the United Kingdom, Germany, Austria, Australia, Canada, and others.
The recall affects all lots of this product. The source document does not specify what actions affected consumers or healthcare facilities should take regarding this recall.
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: 1262 US; 549 OUS Lot/code info: All Lots UDI: 10886982274045
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.