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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67675

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

Open FDA event record

Event summary

Timeline bucket
February 07, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Pega Medical 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

Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.

Z-1448-2014
Recall number
Z-1448-2014
Initiated
February 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Pega Medical Inc.
Quantity
Total of 5 units (2 units in the US and 3 units in Germany)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Male Components in this lot are made of material with lower strength than manufacturing specifications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Male Components in this lot are made of material with lower strength than manufacturing specifications.

Code information

Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS].

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.