Recall Z-2078-2014 ยท EFA Handpiece, Belt And/Or Gear Driven, Dental
Dental EZ Group Star Dental Division
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
| Date | Jul 17, 2014 (initiated Jun 13, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 45 |
| Distribution | US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS Dentalez Group, Mar 28, 1996 |