CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
Check against the official notice below — it lists the full affected range.
Orthofix, Inc. is voluntarily recalling the Rival Reduce Fracture Plating System and Rival View Plating System CC plates in small, medium, and large sizes. The recall was initiated after a complaint investigation found that the locking screws do not properly engage the plates during surgery. The affected products were distributed to consignees across 20 U.S. states and Washington, D.C., with a total of 24 units involved in the recall.
The specific lots affected are identified by their UDI and lot numbers: small plates (UDI 18056099647694, Lot B1099067), medium plates (UDI 18056099647700, Lot B1099061), and large plates (UDI 18056099647717, Lot B1099063). The source document does not specify a remedy or guidance for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Reason for recall: Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. Distribution: U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK, Quantity: 24 Lot/code info: (UDI)/Lot: a) (18056099647694) B1099067; b) (18056099647700) B1099061; c) (18056099647717) B1099063
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.