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Recall Observatory FDA recall evidence

Device product

Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products

Z-2044-2014

May 07, 2012

Class II

Product summary

Firm
MTI Precision Products LLC.
Event
Event 68570
Status
Terminated
Classification
Class II
Quantity
134 devices
Official record key
device-enforcement:Z-2044-2014

Official wording

Reason: Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.

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.

Distribution pattern: US Nationwide Distribution in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.