Medical Device
Manufacturing
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Z-2044-2014Class II

Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products

Mti Precision Products / initiated 2012-05-07 / Terminated / root cause: software

MTI Precision Products LLC. began a recall of Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products on . FDA classified it as Class II and gives the reason as "Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2044-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Mti Precision Products
Product
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
Product code
EFB Handpiece, Air-Powered, Dental
Reason for recall
Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
Root cause tag
software
FDA root cause
Software design (manufacturing process)
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.
Quantity in commerce
134 devices
Distribution
US Nationwide Distribution in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.
Product codes and 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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2044-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2044-2014Class IITerminatedVoluntary: Firm initiated