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FDAApril 6, 2018device

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

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

18056099648592

Recall history

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

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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 — Recall Details · AllClear