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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73293

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

Open FDA event record

Event summary

Timeline bucket
February 08, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ormco/Sybronendo

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

TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment

Z-1083-2016
Recall number
Z-1083-2016
Initiated
February 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ormco/Sybronendo
Quantity
5,568 units total (2,070 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as SM3 which matches the product inside.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as SM3 which matches the product inside.

Code information

GE15011637

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH