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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 Fissuresee related information
Date Initiated by FirmApril 13, 2018
Date PostedMay 14, 2018
Recall Status1 Terminated 3 on April 08, 2019
Recall NumberZ-1883-2018
Recall Event ID 79994
Product Classification Bur, dental - Product Code EJL
ProductAlpen 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
FEI Number 2416455
Recalling Firm/
Manufacturer		 Coltene Whaledent Inc
235 Ascot Pkwy
Cuyahoga Falls OH 44223-3701
For Additional Information ContactNancy 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
ActionCustomers 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 Commerce11
DistributionThe products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
Total Product Life CycleTPLC 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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