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ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL recalls FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Recalled September 4, 2024 · FDA recall Z-2941-2024 · ORTHOPEDIATRICS CANADA ULC
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. · FDA Class II
Units
6 units
Sold at
Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
Description
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.
Product
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Manufacturer(s)
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →