Atlas FDA

Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products

FDA device recall Z-2044-2014 · posted 2014-07-12 · Terminated

Recall details

Recalling firm
MTI Precision Products LLC.
Reason for recall
Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
Action taken
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.
Root cause
Software design (manufacturing process)
Status
Terminated
Product code
EFB
Quantity affected
134 devices
Distribution
US Nationwide Distribution in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.
Date initiated
2012-05-07
Date posted
2014-07-12
Date terminated
2015-03-12
Location
Lakewood, NJ

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
LYNX LOW-SPEED HANDPIECE (K940261)Mti Precision Products1994-12-29