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FDAApril 6, 2018device

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

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

180560996476941805609964770018056099647717

Recall history

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

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CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030) — Recall Details · AllClear