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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63297

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

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Event summary

Timeline bucket
February 21, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Kerr Corporation

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

The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.

Z-0268-2013
Recall number
Z-0268-2013
Initiated
February 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Kerr Corporation
Quantity
45 kits and 87 refills

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction.

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

The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction.

Code information

¿Product Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.