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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71636

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, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
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

IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations

Z-2265-2015
Recall number
Z-2265-2015
Initiated
July 09, 2015
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
Domestic: 27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.

Code information

Batch U15124

Distribution pattern

US Distribution in the states of: PA, IN, IA and SC.