Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
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 due to a defect in which locking screws do not properly engage the plates during surgery. The recalled products are Y-plates manufactured by Orthofix S.r.l. Italy in two sizes: Small (part number 003-C-01001, UDI 18056099647786, Lot B1102163) and Large (part number 003-C-02001, UDI 18056099647793, Lot B1106912). A total of 36 units were distributed to medical facilities across multiple states including New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, Washington D.C., Nevada, Indiana, California, Michigan, Illinois, Maryland, North Carolina, Ohio, and Oklahoma.
The recall notice does not specify a remedy or instructions 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: 36 Lot/code info: (UDI)/Lot: a) (18056099647786) B1102163; (b (18056099647793) B1106912
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.