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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90133

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

Open FDA event record

Event summary

Timeline bucket
June 08, 2020
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
New Standard Device 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

1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

Z-1236-2022
Recall number
Z-1236-2022
Initiated
June 08, 2020
Classification
Class II
Status
Completed
Recalling firm
New Standard Device Inc
Quantity
426

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.

Code information

UDI: 854641008419, Lots: A29518X and A17219DA

Distribution pattern

US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.