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Recall Observatory FDA recall evidence

Device product

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

Z-1472-2014

March 05, 2014

Class II

Product summary

Firm
Pega Medical Inc.
Event
Event 67803
Status
Terminated
Classification
Class II
Quantity
48
Official record key
device-enforcement:Z-1472-2014

Official wording

Reason: 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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label contained the incorrect