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U.S. Department of Health and Human Services

Class 3 Device Recall Titan 3 5K LowSpeed Motor

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  Class 3 Device Recall Titan 3 5K LowSpeed Motor see related information
Date Initiated by Firm August 11, 2010
Date Posted September 02, 2010
Recall Status1 Terminated 3 on December 13, 2010
Recall Number Z-2354-2010
Recall Event ID 56489
510(K)Number K960260  
Product Classification Handpiece, belt and/or gear driven, dental - Product Code EFA
Product Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
Code Information Part number 262261, Lot number 1925391
Recalling Firm/
Manufacturer		 Dental EZ Stardental Division
1816 Colonial Village Ln
Lancaster PA 17601-5891
For Additional Information Contact Kay Engle
866-383-4636 Ext. 4350
Manufacturer Reason
for Recall		 The housing of 5K motor is labeled as a 20K motor.
FDA Determined
Cause 2		 Labeling mix-ups
Action DentalEZ group/Star Dental Division sent a "Medical Device Recall" letter to consignees on 8/11/10, informing them that the device's 5K motor was mislabeled as a 20K motor. Customers are to stop using of the device, and return to the manufacturer or to the distributor using supplied shipping labels. Replacement devices will be sent to customers at no charge. Consignees are to complete and return a form indicating whether they have any affected devices, and whether customers have been contacted about this recall. Customers can contact DentalEZ at 866-383-4636 .
Quantity in Commerce 41 units
Distribution Nationwide Distribution: States of IN and TX
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.
510(K) Database 510(K)s with Product Code = EFA and Original Applicant = DENTALEZ GROUP
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