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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81065

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

Open FDA event record

Event summary

Timeline bucket
August 21, 2018
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

ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.

Z-0376-2019
Recall number
Z-0376-2019
Initiated
August 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Coltene Whaledent Inc
Quantity
30 packets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4

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

ParaPost Plus Titanium Posts contain stainless steel post that are a size 4

Code information

Batch I33012

Distribution pattern

US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.