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Synthes Produktions GmbH recalls MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skelet
Recalled August 5, 2020 · FDA recall Z-2739-2020 · Synthes Produktions
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). · FDA Class II
Units
41 units
Sold at
International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
Description
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).
Product
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.
Manufacturer(s)
Synthes Produktions GmbH
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →