FDA-Device2024-09-04Class II
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
Hazard
During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
Sold states
Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
Affected count
6 units
Manufactured in
1111 Chomedey (A-13) E, Laval, Canada
Products
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2941-2024Don't want to check this manually?
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