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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2044-2014 | Class II | Terminated | Voluntary: Firm initiated |
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