| Class 2 Device Recall DIATECH, ROUND END TAPER | |
Date Initiated by Firm | July 19, 2019 |
Create Date | September 04, 2019 |
Recall Status1 |
Terminated 3 on April 30, 2021 |
Recall Number | Z-2436-2019 |
Recall Event ID |
83396 |
Product Classification |
Bur, dental - Product Code EJL
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Product | DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F |
Code Information |
Lot/Batch Number J22952 |
Recalling Firm/ Manufacturer |
Coltene /Whaledent AG Feldwiesenstrasse 20 Altstatten Sg Switzerland
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Manufacturer Reason for Recall | A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length. |
FDA Determined Cause 2 | Error in labeling |
Action | The firm initiated the recall by email on 07/19/2019 requesting that the consignee return any unused product for replacement. |
Quantity in Commerce | 20 units of 5 burs/unit |
Distribution | GA |
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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