Recall Z-2354-2010 ยท EFA Handpiece, Belt And/Or Gear Driven, Dental
Dental EZ Stardental Division
Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
| Date | Sep 2, 2010 (initiated Aug 11, 2010) |
| Status | Terminated |
| Reason | The housing of 5K motor is labeled as a 20K motor. |
| Root cause | Labeling mix-ups |
| 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 . |
| Quantity | 41 units |
| Distribution | Nationwide Distribution: States of IN and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS Dentalez Group, Mar 28, 1996 |