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Pega Medical Inc. recalls Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in
Recalled April 16, 2014 · FDA recall Z-1448-2014 · Pega Medical
Hazard
The Male Components in this lot are made of material with lower strength than manufacturing specifications. · FDA Class II
Units
Total of 5 units (2 units in the US and 3 units in Germany)
Sold at
Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
Description
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Product
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.
Manufacturer(s)
Pega Medical Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →