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.
FDA Recall Z-2739-2020 · Posted None
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Recalling FirmSynthes Produktions GmbH
Recall StatusTerminated
Product CodeJEY
Date Initiated2020-06-16
Date Terminated2022-04-15
Product Quantity41 units
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).
Firm Action
DePuy Synthes issued urgent field safety notice in June 26, 2020 to notify customers. The affiliates in the impacted countries will notify affected customers.
Root Cause
Under Investigation by firm
Distribution Pattern
International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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