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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85427

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

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Event summary

Timeline bucket
January 14, 2020
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

Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

Z-2286-2020
Recall number
Z-2286-2020
Initiated
January 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
Ormco/Sybronendo
Quantity
2,189 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

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

The bracket torque was mislabeled on the packaging.

Code information

Lot number 031902599

Distribution pattern

Worldwide Distribution: US (nationwide) to states of: AR, AZ, FL, GA, IL, LA, MS, NC, NE, NJ, NY, PA, TN, and TX. Foreign distribution was made to Belgium, Czech Republic, France, Germany, Israel, Italy, Kuwait, Latvia, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland, Tunisia, United Arab Emirates, and United Kingdom.

Field note

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