DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
Check against the official notice below — it lists the full affected range.
DePuy Synthes (USA) Products LLC is recalling the 18.0MM REAMER HEAD FOR RIA 2 STERILE, an orthopedic manual surgical instrument (Part Code: 03.404.032S), nationwide and in multiple countries including the United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, and Singapore. The recall affects 542 units in the U.S. and 154 units outside the U.S. across all lots.
The device is being recalled because the reamer head breakage rate exceeds expected levels when recommended surgical techniques are not followed, which can result in adverse tissue reaction, soft tissue damage, and bone damage. The recall source does not specify a remedy or corrective action 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: 542 US ; 154 OUS Lot/code info: All Lots UDI: 10886982274090
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.