medical Class II Updated 2018-06-13

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

Recalled Product

Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)


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) (18056099647854) B1102026; b) (18056099647878) B1101930; c) (18056099647892) B1098806
View official government recall

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