FDA Medical Device Recalls (openFDA)
Dental EZ Stardental Division: StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
- Recall number
- Z-1522-2013
- Recalling firm
- Dental EZ Stardental Division
- Product
- StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
- Status
- Terminated
- Initiated
- 2013-05-28
- Posted
- 2013-06-07
- Terminated
- 2014-03-18
- 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.
- Root cause
- Equipment maintenance
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Item 200169, lot numbers 2140459 and 2177284; Item 200174, lot numbers 2151776 and 2158861; Item 200276, lot number 2149190; Item 200288, lot number 2143968; Item 200329, lot number 2139572; Item 200339, lot number 2159105; Item 200354, lot number 2149191; Item 200394, lot number 2164110; Item 200402, lot numbers 2143162 and 2156621; Item 200415, lot number 2139573; Item 200418, lot numbers 2153439, 2163438, 2166502, 2171448, 2173003, and 2175575; Item 200433, lot numbers 2153440 and 2171670; Item 200448, lot numbers 2139574, 2157306, and 2167344; Item 200468, lot number 2151894; Item 200473, lot numbers 2146257, 2156268, and 2166207; Item 200483, lot numbers 2141173, 2151723, and 2161240; Item 200496, lot numbers 2144739, 2151899, 2157307 and 2166208.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NME
- Firm FEI
- 2520265
- Firm city
- Lancaster
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28