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

Recall date

July 4, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2941-2024

FDA classification

Class II

Brand / firm

ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL

Sold / distributed

Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System