StarDental Classique — Class II medical device recall Z-1522-2013
Terminated recall by Dental EZ Stardental Division, reported 2013-06-19, distributed nationwide. Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering
| Recall number | Z-1522-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dental EZ Stardental Division, Lancaster, PA, United States |
| Recall initiated | 2013-05-28 |
| Classified | 2013-06-07 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2014-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 3,560 |
| Lot numbers | 2139572, 2139573, 2139574, 2140459, 2141173, 2143162, 2143968, 2144739, 2146257, 2149190, 2149191, 2151723, 2151776, 2151894, 2151899, 2153439, 2153440, 2156268, 2156621, 2157306, 2157307, 2158861, 2159105, 2161240, 2163438, 2164110, 2166207, 2166208, 2166502, 2167344, 2171448, 2171670, 2173003, 2175575, 2177284 |
| Model numbers | 200169, 200174, 200276, 200288, 200329, 200339, 200354, 200394, 200402, 200415, 200418, 200433, 200448, 200468, 200473, 200483, 200496 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1522-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.