T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-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 in two sizes (small part number 003-B-01001 and large part number 003-B-02001). The recall was initiated after a complaint investigation determined that the locking screws do not properly engage the plates during surgery, which could affect the stability of fracture fixation.
A total of 36 units were distributed across multiple U.S. states including New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, and others. The affected products have two specific lot numbers: B1098805 (UDI 18056099647762) and B1102020 (UDI 18056099647779). The recall record does not specify a remedy or instructions for what affected consumers should do.
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) (18056099647762) B1098805; b) (18056099647779) B1102020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.