Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); b) 8MM Spacer (022-H-00008); c) 10MM Spacer (002-H-00010); d) 12MM Spacer (002-H-00012)
Check against the official notice below — it lists the full affected range.
Orthofix, Inc. is voluntarily recalling Evans Plate spacers in sizes 6MM, 8MM, 10MM, and 12MM (Part Numbers 002-H-00006, 022-H-00008, 002-H-00010, and 002-H-00012) due to locking screws that do not properly engage the plates during surgery. The recall affects 52 units distributed to medical facilities in 20 states and the District of Columbia, with lot numbers B1212604, B1099059, B1123627, B1099057, B1099068, and B1099069, all manufactured on November 15, 2017.
The source document does not specify a remedy or instructions for affected consumers or healthcare providers.
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: 52 Lot/code info: Lot: B1212604, Date of Manufacture: 2017-11-15, Use By: 2022-10-15, UDI: a) (18056099647724) B1099059, B1123627; b) (18056099647731) B1099057; c) (18056099647748) B1099068; d (18056099647755) B1099069
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.