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Class 2 Device Recall DIATECH, ROUND END TAPER |
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| 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.
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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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