medical Class II Updated 2018-06-13

Orthofix, Inc recalls Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on l

Recalled Product

Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)

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) (18056099647809) B1096736; b) (18056099647816) B1096738; c) (18056099647823) B1096739
View official government recall

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