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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65283

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Dental EZ Stardental Division

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1522-2013
Recall number
Z-1522-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
3,560

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

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.