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U.S. Department of Health and Human Services

Class 2 Device Recall StarDental Classique(TM) Diamond Dental Bur

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 Class 2 Recall
StarDental Classique(TM) Diamond Dental Bur
see related information
Date Posted June 07, 2013
Recall Status1 Terminated on March 18, 2014
Recall Number Z-1522-2013
Recall Event ID 65283
Product Classification Bur, Diamond Coated, Reprocessed - Product Code NME
Product StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
Code Information Item 200169, lot numbers 2140459 and 2177284; Item 200174, lot numbers 2151776 and 2158861; Item 200276, lot number 2149190; Item 200288, lot number 2143968; Item 200329, lot number 2139572; Item 200339, lot number 2159105; Item 200354, lot number 2149191; Item 200394, lot number 2164110; Item 200402, lot numbers 2143162 and 2156621; Item 200415, lot number 2139573; Item 200418, lot numbers 2153439, 2163438, 2166502, 2171448, 2173003, and 2175575; Item 200433, lot numbers 2153440 and 2171670; Item 200448, lot numbers 2139574, 2157306, and 2167344; Item 200468, lot number 2151894; Item 200473, lot numbers 2146257, 2156268, and 2166207; Item 200483, lot numbers 2141173, 2151723, and 2161240; Item 200496, lot numbers 2144739, 2151899, 2157307 and 2166208.
Recalling Firm/
Manufacturer
Dental EZ Stardental Division
1816 Colonial Village Ln
Lancaster, Pennsylvania 17601-5891
Manufacturer Reason
for Recall
Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action Dental EZ Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter on May 28, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 866-383-4636 ext.4350 for questions regarding this recall.
Quantity in Commerce 3,560
Distribution Worldwide Distribution-USA (nationwide) including the states of CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI, and the country of Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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