FDAApril 6, 2018device

MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

orthofix

UPCs

180560996475571805609964756418056099647571

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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