DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling the 14.5MM Reamer Head for RIA 2, a sterile orthopedic manual surgical instrument (Part Code: 03.404.025S), due to reamer head breakage occurring at rates higher than expected. When recommended surgical techniques are not followed, this breakage can result in adverse tissue reaction, soft tissue damage, and bone damage. The product was distributed nationwide in the United States as well as 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 1,142 units were distributed in the US and 450 units outside the US across all lots.
The source document does not specify what actions affected consumers should take in response to this recall.
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: 1142 US; 450 OUS Lot/code info: All Lots UDI: 10886982274083
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.