Recall Z-2044-2014
MTI Precision Products LLC. · initiated May 7, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
Codes / lots: 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.
Reason for recall
Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
FDA-determined cause: Software design (manufacturing process)
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.
Details
- Recall number
- Z-2044-2014
- Initiated
- May 7, 2012
- Posted by FDA
- July 12, 2014
- Terminated
- March 12, 2015
- Product code
- EFB – Handpiece, Air-Powered, Dental
- Quantity
- 134 devices
- Distribution
- US Nationwide Distribution in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.
- Recalling firm
- MTI Precision Products LLC., Lakewood, NJ