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U.S. Department of Health and Human Services

Class 2 Device Recall Benco Dental Tartar &38; Stain Remover

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  Class 2 Device Recall Benco Dental Tartar &38; Stain Remover see related information
Date Initiated by Firm February 10, 2014
Date Posted March 04, 2014
Recall Status1 Terminated 3 on June 18, 2014
Recall Number Z-1133-2014
Recall Event ID 67475
Product Classification Solution, cement disolving - Product Code KZP
Product BencoDental tartar & stain remover ultrasonic cleaning solution

Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
Code Information Part #1010-451 Lot #13121434 
Recalling Firm/
Manufacturer		 Heraeus Kulzer, LLC.
300 Heraeus Dr
South Bend IN 46614-2557
For Additional Information Contact Doug Pope
574-299-5473
Manufacturer Reason
for Recall		 As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C
FDA Determined
Cause 2		 Labeling mix-ups
Action Heraeus Kulzer, notified their one consignee of the recall February 4, 2014 via phone and then by official electronic notification. On February 7, 2014, an Important Communication Product Recall letter was also mailed to Benco direct accounts. On 2/10/14, Heraeus Kulzer also called Benco customers notifying them of the recall. The notifications explained the issue, identified the affected product and actions to be taken. For questions call 574-293-5444
Quantity in Commerce 812 units (gallons)
Distribution USA Nationwide Distribution in the states AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, ND, NE, NM, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV
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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