medical Class II Updated 2018-06-13

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

Recalled Product

Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)

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) (18056099647786) B1102163; (b (18056099647793) B1106912
View official government recall

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