FDA recall Z-2739-2020

Synthes Produktions GmbH · Class II · device

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.

Reason for recall

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).

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-06-16
Report date
2020-08-05
Termination date
2022-04-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oberdorf Bl, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2739-2020