The Recall Desk
ModerateFDA (Devices)·Z-2078-2014·Announced 2014-07-23

Dental EZ Group Recalls 45 Mislabelled Titan T 5K Dental Motors

Dental EZ Group is recalling 45 Titan T 5K dental motors because the housing was incorrectly laser marked as a 20K motor.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Dental EZ Group Star Dental Division is recalling 45 units of the Titan T 5K Motor. This low-speed dental motor is used with various attachments to perform procedures such as caries removal, finishing, polishing, pin setting, and prophy. The motor has a speed range of 100 to 5000 rpm.

The recall was initiated because the housing of the 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include an additional lot.

The affected units were distributed in the United States in the states of Indiana, Tennessee, Washington, California, Utah, Minnesota, and New York. The recall includes Lot # 2239818 and Lot #2251181, with catalog number 263940. Affected serial numbers range from AC00001M7 to AC00045M7.

The recalled product

Product
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.
Affected units
45

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot # 2239818
  • Model - Titan-T 5K Motor
  • Catalog Number - 263940
  • with serial numbers: AC00001M7
  • AC00002M7
  • AC00003M7
  • AC00004M7
  • AC00005M7
  • AC00006M7
  • AC00007M7
  • AC00008M7
  • AC00009M7
  • AC00010M7
  • AC00011M7
  • AC00012M7
  • AC00013M7
  • AC00014M7
  • AC00015M7
  • AC00016M7
  • AC00017M7

Distribution

Distributed in 7 states:

Same manufacturer · Dental EZ Group Star Dental Division

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