medical Class II Updated 2020-08-05

Synthes Produktions GmbH recalls MatrixMIDFACE Screws - Product Usage: The intended use for t

Recalled 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.


Hazard / Issue

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).

Issued by

FDA

Distribution: International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
Lot/Code Info: Lot # 41P2340
View official government recall

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