FDAFDA · Food and drugs·Recall number Z-1448-2014
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.
Published April 16, 2014 · Recall initiated: February 7, 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 Male Components in this lot are made of material with lower strength than manufacturing specifications.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Pega Medical Inc.
- Distributor
- Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
- Lot
- 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].
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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