L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
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 L-Plates (left and right models). The recall was initiated after an investigation confirmed that the locking screws on these plates do not properly engage during surgery, which could affect their performance. The recalled products were distributed to consignees across 20 U.S. states and Washington, D.C., with 30 units affected across two specific lot numbers.
The recall record does not specify what actions affected consumers should take in response to this recall.
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: 30 Lot/code info: (UDI)/Lot: a) (18056099647830) B1108952; b) (18056099647847) B1108955
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.