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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67861

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

Open FDA event record

Event summary

Timeline bucket
March 25, 2014
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

Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.

Z-1321-2014
Recall number
Z-1321-2014
Initiated
March 25, 2014
Classification
Class II
Status
Terminated
Recalling firm
Ormco/Sybronendo
Quantity
150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.

Code information

Part Number 449-6212, Lot Number 121359169.

Distribution pattern

US and Canada.