FDA Device

Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free

Hazard

The housing of 5K motor is labeled as a 20K motor.

What You Should Do

Remedy

DentalEZ group/Star Dental Division sent a "Medical Device Recall" letter to consignees on 8/11/10, informing them that the device's 5K motor was mislabeled as a 20K motor. Customers are to stop using of the device, and return to the manufacturer or to the distributor using supplied shipping labels. Replacement devices will be sent to customers at no charge. Consignees are to complete and return a form indicating whether they have any affected devices, and whether customers have been contacted about this recall. Customers can contact DentalEZ at 866-383-4636 .

Products

Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
Brand
Dental EZ Stardental Division
UPC
Part number 262261, Lot number 1925391

Units Affected

41 units