FDA Recall
Terminated
Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
Recall: Z-2354-2010
·
Initiated August 11, 2010
Recall
- Recall Number
- Z-2354-2010
- Event Number
- 56489
- Firm
- Dental EZ Stardental Division
- FEI Number
- 2520265
- Product Code
- EFA
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- August 11, 2010
- Posted
- September 2, 2010
- Terminated
- December 13, 2010
- Address
- 1816 Colonial Village Ln, Lancaster, PA, 17601-5891
Description
Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
Reason
The housing of 5K motor is labeled as a 20K motor.
Action
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 .
Distribution
Nationwide Distribution: States of IN and TX
Quantity
41 units