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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93810

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

Open FDA event record

Event summary

Timeline bucket
December 21, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
G & H Wire Company

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

FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56

Z-0976-2024
Recall number
Z-0976-2024
Initiated
December 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
G & H Wire Company
Quantity
81 pk (100/pk)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy

Code information

UDI: 10195291042642 Lot Number: 1120035

Distribution pattern

Worldwide - US Nationwide distribution in the states of UT, MO, WV, TX, NJ and the countries of Canada, France, Germany, New Zealand, South Africa, Thailand.