Synthes Produktions GmbH recalls MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skele…

Recall date

June 16, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2739-2020

FDA classification

Class II

Brand / firm

Synthes Produktions GmbH

Sold / distributed

International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.