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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JEY
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