DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
Check against the official notice below — it lists the full affected range.
DePuy Synthes (USA) Products LLC is recalling the 10.0MM REAMER HEAD FOR RIA 2, a sterile orthopedic manual surgical instrument (Part Code: 03.404.016S). The reamer head is breaking at a higher rate than expected when recommended surgical techniques are not followed, which can result in adverse tissue reaction, soft tissue damage, and bone damage. The affected 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 1,297 units were distributed in the United States and 528 units outside the United States. All lots of this product are included in the recall, and all affected devices can be identified by the UDI 10886982273932. The source document does not specify a remedy or what 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: 1297 US 528 OUS Lot/code info: All Lots UDI: 10886982273932
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.