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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83385

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

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Event summary

Timeline bucket
July 09, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Voco GmbH

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

Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Z-0028-2020
Recall number
Z-0028-2020
Initiated
July 09, 2019
Classification
Class II
Status
Terminated
Recalling firm
Voco GmbH
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The metal cannula are potentially too loose and may become loose when applying the filing material.

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

The metal cannula are potentially too loose and may become loose when applying the filing material.

Code information

Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021

Distribution pattern

Distributed in the US to Iowa and New York

Field note

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