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U.S. Department of Health and Human Services

Class 2 Device Recall Alpen Carbide 702 Cross Cut Tapered Fissure

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  Class 2 Device Recall Alpen Carbide 702 Cross Cut Tapered Fissure see related information
Date Initiated by Firm April 13, 2018
Date Posted May 14, 2018
Recall Status1 Terminated 3 on April 08, 2019
Recall Number Z-1883-2018
Recall Event ID 79994
Product Classification Bur, dental - Product Code EJL
Product Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
Code Information Batch I37640
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 products are labeled with an incorrect product number.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were contacted via telephone call on 4/13/18. The customers were asked the following questions: 1. Confirm that {name of Distributor} received {number of packs} around this date {date}. 2. Confirm that the affected product, lot number I37460, is still in their inventory. a. If not, to whom was it shipped to? [Coltene will need that contact information]. 3. Can you take a picture of the lot number I37460 that you received and send to {Regional sales manager}? 4. Please return the product in question to Coltene per Vendor Return Authorization with full tracking information.
Quantity in Commerce 11
Distribution The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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