StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA device recall Z-1522-2013 · posted 2013-06-07 · Terminated
Recall details
- Recalling firm
- Dental EZ Stardental Division
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- NME
- Quantity affected
- 3,560
- Distribution
- 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.
- Date initiated
- 2013-05-28
- Date posted
- 2013-06-07
- Date terminated
- 2014-03-18
- Location
- Lancaster, PA
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