Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System Recalled by ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL Due to During the assembly of the FRT250 cartridge assembly,...

Date: July 4, 2024
Company: ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL directly.

Affected Products

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

Quantity: 6 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL

ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report