FDA-Device2014-04-16Class II
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.
Pega Medical Inc.
Hazard
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Sold states
Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
Affected count
Total of 5 units (2 units in the US and 3 units in Germany)
Manufactured in
1111 Autoroute Chomedy, N/A, Laval, N/A, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1448-2014Don't want to check this manually?
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