DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
Check against the official notice below — it lists the full affected range.
DePuy Synthes (USA) Products LLC is recalling the 16.0MM REAMER HEAD FOR RIA 2 STERILE, an orthopedic manual surgical instrument (Part Code: 03.404.028S). The reamer head is breaking at a higher than expected rate when recommended surgical techniques are not followed. These breakages can result in adverse tissue reaction, soft tissue damage, and bone damage. The affected product has been distributed nationwide in the United States and internationally to the United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, and Singapore.
A total of 651 units were affected, with 326 distributed in the U.S. and 325 internationally. All lots of this product are included in the recall. The manufacturer has not specified a remedy in this recall record.
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: 651US : 326 OUS Lot/code info: All Lots UDI: 10886982274014
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.