Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)
Check against the official notice below — it lists the full affected range.
Orthofix, Inc. is voluntarily recalling three sizes of sterile box plates from its Rival Reduce Fracture Plating System and Rival View Plating System. A complaint investigation confirmed that the locking screws on these plates do not properly engage during surgery, creating a potential hazard. The recalled devices include 18mm (part number 003-F-18001), 22mm (003-F-22001), and 30mm (003-F-30001) plates, with a total of 54 units distributed across multiple U.S. states including California, Texas, Florida, Pennsylvania, and others.
The recall affects three specific lots identified by their UDI numbers and lot codes: lot B1102026, lot B1101930, and lot B1098806. The source document does not specify a remedy or corrective action 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: 54 Lot/code info: (UDI)/Lot: a) (18056099647854) B1102026; b) (18056099647878) B1101930; c) (18056099647892) B1098806
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.