Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D-20012); d) D 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM (002-D-20018); g) D 2.0MM X
Check against the official notice below — it lists the full affected range.
Orthofix, Inc. is voluntarily recalling non-locking screws distributed as part of the Rival Reduce Fracture Plating System and Rival View Plating System. The screws, manufactured by ORTHOFIX S.r.l. Italy, come in three sizes (2.0MM diameter in lengths of 8MM, 10MM, and 12MM) and were distributed to consignees across 20 U.S. states and Washington, D.C. A total of 601 units affected by this recall have been identified across multiple lot numbers.
The recall was initiated after a complaint investigation confirmed that the locking screws do not properly engage the plates during surgery, creating a potential safety risk. The recall record does not specify a remedy or instructions for what affected consumers should do 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: 601 Lot/code info: (UDI)/Lot: a) (18056099645614) B1204542, B1101808; b) (18056099645621) B1204969, B1201169, B1075101; c) (18056099645638) B1204554, B1195701, B1075428; d) (18056099645645) B1204971, B1201176, B1075846; e) (18056099645652) B1195727, B1204266, B1075426; f) (18056099645669) B1204540, B1075429; g) (18056099645676) B1204541, B1075425; h) (18056099645683) B1204539, B1075177; i) (18056099645690) B1204972, B1195700, B1075847; j) (18056099645706) B1204555, B1195702, B1075427; k) (18056099645713) B1204973, B1201170, B1075430; l) (18056099645720) B1075825, B1201166, B1204270
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.