Date Initiated by Firm | October 20, 2020 |
Create Date | November 17, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0466-2021 |
Recall Event ID |
86694 |
Product Classification |
Bur, dental - Product Code EJL
|
Product | Clinic Pack 100
Pieces FG 57
100057C (100057C) |
Code Information |
J74027 |
Recalling Firm/ Manufacturer |
Coltene Whaledent Inc 235 Ascot Pkwy Cuyahoga Falls OH 44223-3701
|
For Additional Information Contact | Nancy Spencer 330-916-8995 |
Manufacturer Reason for Recall | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On October 20, 2020, the firm emailed Urgent Medical Device Recall letters to affected distributors. Customers were informed that the incorrect dental carbide bur was manufactured and subsequently packaged and distributed.
Customers were asked to return the product to Coltene/Whaledent, Inc. by following the instructions in the letter. The firm will replace the product at no cost. Please inform the firm if you have already used the product. Distributors were asked to either identify and notify their customers who were shipped the affected product or to provide a list of affected customers to the recalling firm so that Coltene/Whaledent, Inc. could notify them. |
Quantity in Commerce | 556 |
Distribution | Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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