MatrixNEURO 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-2698-2020 · Posted None
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Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeJEY
Date Initiated2020-06-18
Date Terminated2021-04-13
Product Quantity104 units
Reason for Recall
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
Firm Action
DePuy Synthes issued urgent field safety notice in June 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 countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
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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