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FDAJune 16, 2020device

MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.

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

The hazard

One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).

What to do

FDA enforcement status: Terminated

Brands named

synthes produktionssynthes

Recall history

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

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