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U.S. Department of Health and Human Services

Class 2 Device Recall MatrixNEURO Screws

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 Class 2 Device Recall MatrixNEURO Screwssee related information
Date Initiated by FirmJune 18, 2020
Create DateJuly 24, 2020
Recall Status1 Terminated 3 on April 13, 2021
Recall NumberZ-2698-2020
Recall Event ID 85899
510(K)NumberK042365 
Product Classification Plate, bone - Product Code JEY
ProductMatrixNEURO 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 # 30P6198
Recalling Firm/
Manufacturer
Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information ContactShannon Rook
610-314-2088
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by firm
ActionDePuy Synthes issued urgent field safety notice in June 2020 to notify customers. The affiliates in the impacted countries will notify affected customers.
Quantity in Commerce104 units
DistributionInternational distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
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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