DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
Check against the official notice below — it lists the full affected range.
DePuy Synthes (USA) Products LLC is recalling the 12.0MM Reamer Head for RIA 2, a sterile orthopedic manual surgical instrument (Part Code: 03.404.020S), nationwide and in multiple foreign countries including the United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, and Singapore. The recall involves 1,566 units distributed in the US and 732 units distributed outside the US across all lots with UDI 10886982273987.
The reamer head breakage occurs at rates higher than expected, which can result in adverse tissue reactions, soft tissue damage, and bone damage when recommended surgical techniques are not followed. The source document does not specify what action affected consumers should take.
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: 1566 US ; 732 OUS Lot/code info: All Lots UDI: 10886982273987
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.