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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83396

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

Open FDA event record

Event summary

Timeline bucket
July 19, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Coltene /Whaledent AG

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

DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

Z-2436-2019
Recall number
Z-2436-2019
Initiated
July 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Coltene /Whaledent AG
Quantity
20 units of 5 burs/unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.

Code information

Lot/Batch Number J22952

Distribution pattern

GA

Field note

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