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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67803

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

Open FDA event record

Event summary

Timeline bucket
March 05, 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

Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.

Z-1472-2014
Recall number
Z-1472-2014
Initiated
March 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Pega Medical Inc.
Quantity
48

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label contained the incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.

Code information

Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13

Distribution pattern

Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.