medical Class II Updated 2018-06-13

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

Recalled Product

TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)

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) (18056099647663) B1099060; b) (18056099647670) B1099062; c) (18056099647687) B1099066
View official government recall

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