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FDAMay 9, 2019device

Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.

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

The hazard

The titanium implant has the wrong article number laser marked on it.

What to do

FDA enforcement status: Ongoing

Brands named

i t s

Recall history

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

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Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed. — Recall Details · AllClear