Z-2941-2024 Class II Ongoing

Recalled by ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL — Laval

Recall Details

Product Type
Devices
Report Date
September 4, 2024
Initiation Date
July 4, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

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 Pattern

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

Code Information

Part Number FRT250; Lot Numbers: F281-04, F462-02