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Recall Observatory FDA recall evidence

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.

Z-2739-2020

June 16, 2020

Class II

Product summary

Firm
Synthes Produktions GmbH
Event
Event 85951
Status
Terminated
Classification
Class II
Quantity
41 units
Official record key
device-enforcement:Z-2739-2020

Official wording

Reason: 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).

Code information: Lot # 41P2340

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).