DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
Check against the official notice below — it lists the full affected range.
DePuy Synthes is recalling 14.0MM reamer heads for RIA 2 sterile orthopedic surgical instruments nationwide and internationally due to a higher-than-expected rate of breakage during use. When the reamer head breaks and recommended surgical techniques are not followed, patients may experience adverse tissue reactions, soft tissue damage, and bone damage. The recall affects 1,328 units distributed in the United States and 578 units distributed internationally across multiple countries including the United Kingdom, Germany, Australia, Canada, and others. All lot numbers with the UDI 10886982274069 are included in this recall.
The record 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: 1328 US ; 578 OUS Lot/code info: All Lots UDI: 10886982274069
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.