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Terminated

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

FDA Recall Z-1522-2013 · Posted 2013-06-07

Recalling FirmDental EZ Stardental Division
Recall StatusTerminated
Product CodeNME
Date Initiated2013-05-28
Date Terminated2014-03-18
Product Quantity3,560

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.

Firm Action

Dental EZ Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter on May 28, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 866-383-4636 ext.4350 for questions regarding this recall.

Root Cause

Equipment maintenance

Distribution Pattern

Worldwide Distribution-USA (nationwide) including the states of CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI, and the country of Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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