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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87645

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

Open FDA event record

Event summary

Timeline bucket
March 18, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use 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. Model number/Catalog number: L741

Z-1494-2021
Recall number
Z-1494-2021
Initiated
March 18, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Coltene Whaledent Inc
Quantity
65 packs of 20 pins

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The incorrect dental pins were packaged and subsequently distributed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The incorrect dental pins were packaged and subsequently distributed.

Code information

Lot/Batch number: K39841

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.