DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling the 15.5MM REAMER HEAD FOR RIA 2 STERILE orthopedic surgical instrument (Part Code: 03.404.027S) nationwide and internationally. The reamer head is breaking at a rate higher than expected when recommended surgical techniques are not followed, which can result in adverse tissue reactions, soft tissue damage, and bone damage.
The recall affects 642 units in the United States and 325 units internationally across countries including the United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, the United Kingdom, Ireland, Israel, Italy, and Singapore. All lots of this product are included in the recall. The source 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: 642 US; 325 OUS Lot/code info: All Lots UDI:10886982273994
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.