Orthofix, Inc: MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)

Is my product affected?

MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)

• UPC 18056099647557
• UPC 18056099647564
• UPC 18056099647571

Check against the official notice below — it lists the full affected range.

What happened

Orthofix, Inc. is voluntarily recalling the Rival Reduce Fracture Plating System and Rival View Plating System, which are surgical devices used for bone fracture repair. The recall was initiated after a complaint investigation determined that the locking screws on these plates do not properly engage during surgery, which could compromise their function. The affected devices were distributed to medical facilities across the United States, including locations in New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, Washington D.C., Nevada, Indiana, California, Michigan, Illinois, Maryland, North Carolina, Ohio, and Oklahoma.

The recalled MTP plates come in three sizes (small, medium, and large) and are manufactured by ORTHOFIX S.r.l. Italy. Specific lot numbers associated with this recall include B1098799, B1115575, B1113628, and B1098800. The source document does not specify what remedy affected consumers should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: N/A Lot/code info: (UDI)/Lot: a) (18056099647557) B1098799, B1115575; (18056099647564) B1113628; (18056099647571) B1098800

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C2018-04-06
• Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C2018-04-06
• Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C2018-04-06
• 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 2018-04-06
• Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 12MM (002-E-20012); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D 2.0MM X 18MM (002-E-20018); g) 2018-04-06

All FDA (Device enforcement) recalls