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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66276

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

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Event summary

Timeline bucket
September 13, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

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

NX3 Try-In Gel. The product is used as a tooth shade resin material.

Z-2259-2013
Recall number
Z-2259-2013
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
197 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.

Code information

Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.

Distribution pattern

Worldwide Distribution, including Nationwide in the US and the countries of Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil and Saudi Arabia.