medical Class II Updated 2018-06-13

Orthofix, Inc recalls MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label,

Recalled Product

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)

Hazard / Issue

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.

Issued by

FDA

Affected States: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK
Lot/Code Info: (UDI)/Lot: a) (18056099647557) B1098799, B1115575; (18056099647564) B1113628; (18056099647571) B1098800
View official government recall

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