DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling the 15.0MM Reamer Head for RIA 2, a sterile orthopedic manual surgical instrument (Part Code: 03.404.026S), across all lots nationwide and internationally. The recall was initiated because the reamer head is breaking at a rate higher than expected, particularly when recommended surgical techniques are not followed. These breakages can result in adverse tissue reactions, soft tissue damage, and bone damage to patients.
A total of 748 units were distributed in the United States and 381 units were distributed internationally to countries including the United Kingdom, Germany, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Spain, Ireland, Israel, Italy, Singapore, and the United Arab Emirates. The source does not specify what remedy or corrective 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: 748 US; 381 OUS Lot/code info: All Lots UDI: 10886982273956
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.