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.