FDA-Device2014-07-23Class II

Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.

Dental EZ Group Star Dental Division
Hazard

The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.

Sold states
US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY.
Affected count
45
Manufactured in
1816 Colonial Village Ln, N/A, Lancaster, PA, United States
Products
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2078-2014

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