FDAFDA · Food and drugs·Recall number Z-1472-2014
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
Published April 30, 2014 · Recall initiated: March 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Pega Medical Inc.
- Distributor
- Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.
- Lot
- Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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