CLASS II Device recall · Reported 19 Jun 2013 · FDA Enforcement Report

StarDental Classique(TM) Diamond Dental Bur recalled

Dental EZ Stardental Division is recalling StarDental Classique(TM) Diamond Dental Bur, distributed nationwide in the US. The recall was initiated on 28 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 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.

Quantity recalled3,560

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1522-2013
FDA event ID: 65283
Recalling firm: Dental EZ Stardental Division, Lancaster, PA
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2013
FDA classified: 7 Jun 2013
Reported: 19 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Dental Devices

Timeline

28 May 2013	Recall initiated by company
7 Jun 2013	Classified by FDA	+10 days
19 Jun 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide California Florida Iowa Indiana New Jersey Nevada New York Pennsylvania Tennessee Texas Wisconsin

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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