Date Initiated by Firm | June 16, 2020 |
Create Date | July 30, 2020 |
Recall Status1 |
Terminated 3 on April 15, 2022 |
Recall Number | Z-2739-2020 |
Recall Event ID |
85951 |
510(K)Number | K050608 |
Product Classification |
Plate, bone - Product Code JEY
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Product | MatrixMIDFACE 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
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For Additional Information Contact | Kimberly 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 |
Action | DePuy 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 Commerce | 41 units |
Distribution | International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan. |
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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