Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e) Small/2MM Step/Left (002-C-01002L);
Check against the official notice below — it lists the full affected range.
Orthofix, Inc. is voluntarily recalling certain Lapidus Plate orthopedic implants used in surgical plating systems. The recall involves 156 units of the Rival Reduce Fracture Plating System and Rival View Plating System distributed across multiple U.S. states. The locking screws in these plates were found to not properly engage the plates during surgery, which was discovered during a complaint investigation.
The affected products are identified by specific part numbers, UDI codes, and lot numbers listed in the recall notice. The recall notice does not specify a remedy or recommended action for consumers who may have received these devices.
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: 156 Lot/code info: (UDI)/Lot: a) (18056099647588) B1096741; b) (18056099647595) B1117260, B1099064; c) (18056099647625) B1117352, B1096743; d) (18056099647632) B1099065 e) (18056099647601) B1117265, f) (18056099647618) B1098803, B1116361; g) 18056099647649) B1200565, B1116364; h) (18056099647656) B1123046,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.