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U.S. Department of Health and Human Services

Class 2 Device Recall Alpen Clinic 100 Carbide Instruments

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  Class 2 Device Recall Alpen Clinic 100 Carbide Instruments see related information
Date Initiated by Firm October 20, 2020
Create Date November 17, 2020
Recall Status1 Open3, Classified
Recall Number Z-0464-2021
Recall Event ID 86694
Product Classification Bur, dental - Product Code EJL
Product Alpen Clinic 100 Carbide Instruments (R100057C)
Code Information J75023
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 packs
Distribution Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Total Product Life Cycle TPLC Device Report
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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