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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95077

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

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Event summary

Timeline bucket
July 04, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL

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

FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System

Z-2941-2024
Recall number
Z-2941-2024
Initiated
July 04, 2024
Classification
Class II
Status
Ongoing
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.

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

During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.

Code information

Part Number FRT250; Lot Numbers: F281-04, F462-02

Distribution pattern

Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.