DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling the 17.5MM Reamer Head for RIA 2, a surgical instrument used in orthopedic procedures. The reamer head is breaking at a higher rate than expected when surgeons do not follow recommended surgical techniques. These breakages can cause adverse tissue reactions, soft tissue damage, and bone damage during surgery. The recall affects 515 units in the United States and 150 units internationally across multiple countries including the United Kingdom, Canada, Australia, and several European nations.
This recall applies to all lots of the product identified by UDI 10886982274076. The source document does not specify a remedy for affected consumers or healthcare facilities.
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: 515 US; 150 OUS Lot/code info: All Lots UDI: 10886982274076
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.