Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM (002-E-27018); g) D 2.7MM X 20MM
Check against the official notice below — it lists the full affected range.
Orthofix, Inc. is voluntarily recalling 1,302 locking screws in three sizes (2.7mm diameter in 8mm, 10mm, and 12mm lengths) used with the Rival Reduce Fracture Plating System and Rival View Plating System. A complaint investigation confirmed that these locking screws do not properly engage the plates during surgery, which could affect the stability of the implant during a surgical procedure.
The recalled screws were distributed to consignees across 20 states and Washington, D.C., including New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, Nevada, Indiana, California, Michigan, Illinois, Maryland, North Carolina, Ohio, Oklahoma, and others. The record 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: 1302 Lot/code info: (UDI)/Lot: a) (18056099646338) B1075104; b) (18056099646345) B1071537, B1083847; c) (18056099646352) B1068544, B1075103; d) (18056099646369) B1075176; e) (18056099646376) B1075838; f) (18056099646383) B1069676, B1082189; g) (18056099646390) B1071602, B1082231; h) (18056099646406) B1069678, B1084787; i) (18056099646413) B1071672, B1082227, B1071672, B1075052; j) (18056099646420) B1082238; k) (18056099646437) B1084801; l) (18056099646444) B1082214, B1204276; m) (18056099646451) B1215467, B1089836; n) (18056099646468) B1215470, B1089877; o) (18056099646475) B1215466, B1089894; p) (18056099646482) B1195749, B1082234; q) (18056099646499) B1204583, B1089842
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.