DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling the 12.5MM REAMER HEAD FOR RIA 2 STERILE (Part Code: 03.404.021S), an orthopedic manual surgical instrument used in procedures. The reamer head is breaking at a higher than expected rate when recommended surgical techniques are not followed, which can result in adverse tissue reaction, soft tissue damage, and bone damage to patients. A total of 1,337 units were distributed in the United States and 453 units were distributed internationally across multiple countries including the United Kingdom, Australia, Canada, and others. All lot numbers are affected.
The recall affects all lots of this product as indicated by the UDI number 10886982274007. The source document does not specify a remedy or instructions for what affected consumers or healthcare facilities should do in response to 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: 1337 US; 453 OUS Lot/code info: All Lots UDI: 10886982274007
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.