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U.S. Department of Health and Human Services

Class 2 Device Recall MatrixMIDFACE Screws

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 Class 2 Device Recall MatrixMIDFACE Screwssee related information
Date Initiated by FirmJune 16, 2020
Create DateJuly 30, 2020
Recall Status1 Terminated 3 on April 15, 2022
Recall NumberZ-2739-2020
Recall Event ID 85951
510(K)NumberK050608 
Product Classification Plate, bone - Product Code JEY
ProductMatrixMIDFACE 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.
Code Information Lot # 41P2340
Recalling Firm/
Manufacturer
Synthes Produktions GmbH
Eimattstrasse 3
Oberdorf Bl Switzerland
For Additional Information ContactKimberly Long
574-221-8156
Manufacturer 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).
FDA Determined
Cause 2
Under Investigation by firm
ActionDePuy Synthes issued urgent field safety notice in June 26, 2020 to notify customers. The affiliates in the impacted countries will notify affected customers.
Quantity in Commerce41 units
DistributionInternational distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JEY
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