Reported Jul 23, 2014 · Terminated

Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental…

Dental EZ Group Star Dental Division

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dental EZ Group Star Dental Division · 1816 Colonial Village Ln · Lancaster, PA · 17601-5891

Is this the product you have?

  • Titan T 5K Motor Product UsageLow-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
Lot codes and dates
    • Lot # 2239818
    • Model - Titan-T 5K Motor
    • Catalog Number - 263940
  • with serial numbersAC00001M7, AC00002M7, AC00003M7, AC00004M7, AC00005M7, AC00006M7, AC00007M7, AC00008M7, AC00009M7, AC00010M7, AC00011M7, AC00012M7 , AC00013M7, AC00014M7, AC00015M7, AC00016M7, AC00017M7, AC00018M7, AC00019M7, AC00020M7, AC00021M7, AC00022M7, AC00023M7, AC00024M7, AC00025M7 The recall was expanded in September 2014 to include additional lot #2251181 (catalog #263940)
  • with serial numbers
    • AC00026M7
    • AC00027M7
    • AC00028M7
    • AC00029M7
    • AC00030M7
    • AC00031M7
    • AC00032M7
    • AC00033M7
    • AC00034M7
    • AC00035M7
    • AC00036M7
    • AC00037M7
    • AC00038M7
    • AC00039M7
    • AC00040M7
    • AC00041M7
    • AC00042M7
    • AC00043M7
    • AC00044M7
    • AC00045M7
Amount recalled
45

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 24, 2015 · Data as of Sep 19, 4:52 PM UTC

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