Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedur
FDA device recall Z-2078-2014 · posted 2014-07-17 · Terminated
Recall details
- Recalling firm
- Dental EZ Group Star Dental Division
- Reason for recall
- The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
- Action taken
- Star Dental sent a Medical Device Recall letter, dated June 13, 2014 to affected customers. This letter identified the affected product, problem, and actions to be taken. For question call 866-383-4636 extension 4350. The recall was expanded in September 2014 to include additional lot #2251181. A letter, dated September 2014 was sent to customers who were impacted by the recall expansion.
- Root cause
- Process control
- Status
- Terminated
- Product code
- EFA
- Quantity affected
- 45
- Distribution
- US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY.
- Date initiated
- 2014-06-13
- Date posted
- 2014-07-17
- Date terminated
- 2015-02-24
- 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 |