FDA-Device2020-08-05Class II
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.
Synthes Produktions GmbH
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).
Sold states
International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
Affected count
41 units
Manufactured in
Eimattstrasse 3, N/A, Oberdorf Bl, N/A, Switzerland
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2739-2020Don't want to check this manually?
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