FDA recall Z-2941-2024

ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2024-07-04
Report date: 2024-09-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Laval, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2941-2024