DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling the 17.0MM Reamer Head for RIA 2, a sterile surgical instrument used in orthopedic procedures (Part Code: 03.404.030S). The reamer head can break during use at a higher rate than expected, which may cause tissue reactions, soft tissue damage, or bone damage if recommended surgical techniques are not followed. The recall affects 572 units distributed in the United States and 200 units distributed internationally in countries including the United Kingdom, Canada, Australia, and others. All lots of this product are included in the recall.
The record does not specify what affected consumers or medical 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: 572 US; 200 OUS Lot/code info: All Lots UDI: 10886982274052
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.