Events

Recall of Device Recall Lynx TM20 Torquemaster Low Speed Handpiece

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MTI Precision Products LLC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68570
  • Event Risk Class
    Class 2
  • Event Number
    Z-2044-2014
  • Event Initiated Date
    2012-05-07
  • Event Date Posted
    2014-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128235
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Handpiece, air-powered, dental - Product Code EFB
  • Reason
    Sharp edge on the body/housing of the lynx tm20 torquemaster low speed handpiece.
  • Action
    MTI 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.

Device

Device Recall Lynx TM20 Torquemaster Low Speed Handpiece
  • Model / Serial
    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.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.
  • Product Description
    Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
  • Manufacturer
    MTI Precision Products LLC.

Manufacturer

MTI Precision Products LLC.
  • Manufacturer Address
    MTI Precision Products LLC., 730 Airport Rd Suite 1, Lakewood NJ 08701-5994
  • Source
    USFDA