Recall Z-1522-2013— Dental EZ Stardental Division

Name: FDA recall Z-1522-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-28

Class II · Terminated

Class II FDA medical device recall by Dental EZ Stardental Division, initiated 2013-05-28, terminated 2014-03-18. FDA's recall record names no specific 510(k) clearance for this event. Product: StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.. Reason: Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots..

Recalling firm: Dental EZ Stardental Division
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Terminated: 2014-03-18
Firm location: Lancaster, PA, United States

Product description

StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

Reason for recall

Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.

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