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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67640

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

Open FDA event record

Event summary

Timeline bucket
December 11, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Coltene Whaledent 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

Latex Dental Dams labeled as Non-Latex Dental Dams

Z-2151-2014
Recall number
Z-2151-2014
Initiated
December 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Coltene Whaledent Inc
Quantity
32 boxes, 15 individual dams per box

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.

Code information

Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10

Distribution pattern

Distributed in Memphis, TN.