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FDAApril 6, 2018device

H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001)

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

1805609964790818056099647915180560996479391805609964795318056099647960

Recall history

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

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H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001) — Recall Details · AllClear