DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling the 11.0MM REAMER HEAD FOR RIA 2 STERILE orthopedic manual surgical instrument (Part Code: 03.404.018S) because the reamer head breaks more frequently than expected. When breakage occurs during surgery, it can cause adverse tissue reactions, soft tissue damage, and bone damage, particularly when recommended surgical techniques are not followed. The recall affects all lots of this product, which was distributed nationwide in the United States as well as internationally to multiple countries including the United Kingdom, Germany, Australia, and others.
A total of 1,275 units were distributed in the US and 445 units were distributed outside the US. The source document does not specify a remedy or corrective action for affected consumers.
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: 1275 US and 445 OUS Lot/code info: All Lots UDI: 10886982273963
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.