Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MatrixNEURO Screws

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MatrixNEURO Screws see related information
Date Initiated by Firm June 18, 2020
Create Date July 24, 2020
Recall Status1 Terminated 3 on April 13, 2021
Recall Number Z-2698-2020
Recall Event ID 85899
510(K)Number K042365  
Product Classification Plate, bone - Product Code JEY
Product 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.
Code Information Lot # 30P6198
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Shannon 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
Action DePuy Synthes issued urgent field safety notice in June 2020 to notify customers. The affiliates in the impacted countries will notify affected customers.
Quantity in Commerce 104 units
Distribution International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JEY and Original Applicant = SYNTHES (USA)
-
-