Recall Z-2078-2014— Dental EZ Group Star Dental Division

Name: FDA recall Z-2078-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-13

Class II · Terminated

Class II FDA medical device recall by Dental EZ Group Star Dental Division, initiated 2014-06-13, terminated 2015-02-24. It names one FDA 510(k) clearance: K960260. Product: 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.. 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..

Recalling firm: Dental EZ Group Star Dental Division
Classification: Class II
Status: Terminated
Initiated: 2014-06-13
Terminated: 2015-02-24
Firm location: Lancaster, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K960260 — STAR TITAN SERIES MOTORS & ATTACHMENTSDentalez Group·cleared 1996-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.