Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
FDA device recall Z-2354-2010 · posted 2010-09-02 · Terminated
Recall details
- Recalling firm
- Dental EZ Stardental Division
- Reason for recall
- The housing of 5K motor is labeled as a 20K motor.
- Action taken
- 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 .
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- EFA
- Quantity affected
- 41 units
- Distribution
- Nationwide Distribution: States of IN and TX
- Date initiated
- 2010-08-11
- Date posted
- 2010-09-02
- Date terminated
- 2010-12-13
- Location
- Lancaster, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAR TITAN SERIES MOTORS & ATTACHMENTS (K960260) | Dentalez Group | 1996-03-28 |