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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93796

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

Open FDA event record

Event summary

Timeline bucket
December 21, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ivoclar Vivadent, Inc.

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

Article No. NA6050411, Valiant PhD No. 1 Econo

Z-1006-2024
Recall number
Z-1006-2024
Initiated
December 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
2 boxes (500 per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.

Code information

UDI-DI D707NA60504110, Lot Z066SD

Distribution pattern

US Nationwide distribution in the states IN and TN.