DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling 10.5MM reamer heads for RIA 2 sterile orthopedic surgical instruments distributed nationwide and internationally. The reamer heads are breaking more often than expected when recommended surgical techniques are not followed, which can cause adverse tissue reactions, soft tissue damage, and bone damage. The recall affects 1,066 units in the United States and 397 units internationally across countries including the United Kingdom, Australia, Canada, and others. All lots with the UDI code 10886982273949 are included in the recall.
The manufacturer has not specified a remedy for affected consumers in the recall record.
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: 1066 US; 397 OUS Lot/code info: All Lots UDI: 10886982273949
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.