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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92851

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

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Event summary

Timeline bucket
July 21, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Keystone Industries

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

Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526

Z-2579-2023
Recall number
Z-2579-2023
Initiated
July 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Keystone Industries
Quantity
337 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

Code information

UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.