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U.S. Department of Health and Human Services

Class 2 Device Recall Lynx TM20 Torquemaster Low Speed Handpiece

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 Class 2 Device Recall Lynx TM20 Torquemaster Low Speed Handpiecesee related information
Date Initiated by FirmMay 07, 2012
Date PostedJuly 12, 2014
Recall Status1 Terminated 3 on March 12, 2015
Recall NumberZ-2044-2014
Recall Event ID 68570
510(K)NumberK940261 
Product Classification Handpiece, air-powered, dental - Product Code EFB
ProductLynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
Code Information P/N Lynx TM20-4H-01: T41202012, T41202013, T41203001, T41203002, T41203003, T41203010, T41204001 to T41204006  P/N Lynx TM20-4H-03 distributed to end user accounts with serial number T41204001  P/N Lynx TM20-2H-03 distributed to Medidenta private labeled as "Meditorque I 20 K" with serial numbers M21203001 to M21203025.  P/N Lynx distirbuted to Medidenta private labeled as "Meditorque I 20 K" with serial numbers M21203026 to M21203055.  P/N Lynx TM20-4H-01 distributed to Johnson-Promident with serial numbers T41204001-T41204020  P/N Lynx TM20-2H-01 distirbuted to Johnson-Promident with serial numbers T21204001-T21204020.  
FEI Number 2246821
Recalling Firm/
Manufacturer		 MTI Precision Products LLC.
730 Airport Rd Suite 1
Lakewood NJ 08701-5994
For Additional Information ContactMr. Haye Hinrichs
800-367-9290
Manufacturer Reason
for Recall		Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
FDA Determined
Cause 2		Software design (manufacturing process)
ActionMTI notified their customers via e-mail on 5/712 and 5/8/12. MTI sent end-users recall letters on or about 5/9/12.
Quantity in Commerce134 devices
DistributionUS Nationwide Distribution in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.
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.
510(K) Database510(K)s with Product Code = EFB
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