TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-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 in three sizes (small, medium, and large). The recall was initiated after a complaint investigation confirmed that the locking screws on these plates do not properly engage during surgery, which could affect their ability to function as intended.
The affected products were distributed to medical facilities across multiple U.S. states including New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, and others. The recall involves 24 units identified by specific lot numbers: B1099060, B1099062, and B1099066. The source document does not specify a remedy 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) (18056099647663) B1099060; b) (18056099647670) B1099062; c) (18056099647687) B1099066
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.