Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020) g) D 3.2MM X 22MM (002-
Check against the official notice below — it lists the full affected range.
Orthofix, Inc. is voluntarily recalling locking screws for the Rival Reduce Fracture Plating System and Rival View Plating System. The screws come in three sizes (3.2mm diameter in 10mm, 12mm, and 14mm lengths) and were distributed to healthcare facilities across multiple U.S. states including New Jersey, Florida, Pennsylvania, and others. A total of 1,574 units were distributed, identified by specific lot and UDI codes listed in the recall notice.
The recall was initiated after a complaint investigation confirmed that the locking screws do not properly engage the plates during surgery. The recall 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: 1574 Lot/code info: (UDI)/Lot: a) (18056099646505) B1075433; b) (18056099646512) B1075434; c) (18056099646529) B1075844; d) (18056099646536) B1075432; e) (18056099646543) B1075436; f) (18056099646550) B1075826; g) (18056099646567) B1075837; h) (18056099646574) B1084804; i) (18056099646581) B1075835; j) (18056099646598) B1082233; k) (18056099646604) B1204272, B1075829; l) (18056099646611) B1204977, B1082245; m) (18056099646628) B1215471, B1204978, B1082247; n) (18056099646635) B1204979, B1084800; o) (18056099646642) B1204582, B1082248; p) (18056099646659) B1218842, B1204980; q) (18056099646666) B1218840, B1204271, B1089889; r) (18056099646673) B1218843, B1195750, B1083640; s) (18056099646680) B1204981, B1083837; t) (18056099646697) B1204982, B1083846; u) (18056099646703) B1204584, B1083852, B1071600, B1071601
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.