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U.S. Department of Health and Human Services

Class 2 Device Recall Titan T 5K Motor

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  Class 2 Device Recall Titan T 5K Motor see related information
Date Initiated by Firm June 13, 2014
Date Posted July 17, 2014
Recall Status1 Terminated 3 on February 24, 2015
Recall Number Z-2078-2014
Recall Event ID 68609
510(K)Number K960260  
Product Classification Handpiece, belt and/or gear driven, dental - Product Code EFA
Product Titan T 5K Motor

Product Usage:
Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
Code Information Lot # 2239818, Model - Titan-T 5K Motor, Catalog Number - 263940, with serial numbers: AC00001M7, AC00002M7, AC00003M7, AC00004M7, AC00005M7, AC00006M7, AC00007M7, AC00008M7, AC00009M7, AC00010M7, AC00011M7, AC00012M7 , AC00013M7, AC00014M7, AC00015M7, AC00016M7, AC00017M7, AC00018M7, AC00019M7, AC00020M7, AC00021M7, AC00022M7, AC00023M7, AC00024M7, AC00025M7  The recall was expanded in September 2014 to include additional lot #2251181 (catalog #263940) with serial numbers: AC00026M7, AC00027M7, AC00028M7, AC00029M7 , AC00030M7, AC00031M7, AC00032M7, AC00033M7, AC00034M7,  AC00035M7 , AC00036M7, AC00037M7, AC00038M7, AC00039M7, AC00040M7, AC00041M7 , AC00042M7, AC00043M7, AC00044M7, AC00045M7.    
Recalling Firm/
Manufacturer		 Dental EZ Group Star Dental Division
1816 Colonial Village Ln
Lancaster PA 17601-5891
For Additional Information Contact Customer Support
717-291-1161
Manufacturer Reason
for Recall		 The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
FDA Determined
Cause 2		 Process control
Action Star Dental sent a Medical Device Recall letter, dated June 13, 2014 to affected customers. This letter identified the affected product, problem, and actions to be taken. For question call 866-383-4636 extension 4350. The recall was expanded in September 2014 to include additional lot #2251181. A letter, dated September 2014 was sent to customers who were impacted by the recall expansion.
Quantity in Commerce 45
Distribution US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY.
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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