medical Class II Updated 2018-06-13

Orthofix, Inc recalls Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.

Recalled Product

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-011C

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: 18056099648592, B1115657, B1107222, B1107223
View official government recall

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