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FDA (Device enforcement)Recalled 2024-07-04class ii

ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL: FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands. Quantity: 6 units Lot/code info: Part Number FRT250; Lot Numbers: F281-04, F462-02

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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