DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
Check against the official notice below — it lists the full affected range.
DePuy Synthes (USA) Products LLC is recalling the 13.0MM REAMER HEAD FOR RIA 2 STERILE, an orthopedic manual surgical instrument (Part Code: 03.404.022S), distributed nationwide and internationally. The reamer head is breaking more often than expected when recommended surgical techniques are not followed, which can result in adverse tissue reaction, soft tissue damage, and bone damage.
The recall affects 1,447 units in the United States and 554 units outside the United States, distributed to countries including the United Kingdom, Germany, Canada, Australia, and others. All lots of this product are included in the recall. The source document does not specify a remedy 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: 1447 US; 554 OUS Lot/code info: All Lots UDI: 10886982274021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.