Class II

Medical Device Recall: FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System

ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL · July 4, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

6 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2941-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.