# FDA recall Z-2941-2024

> **ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL** · Class II · device recall initiated 2024-07-04.

## 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

- **Recall number:** Z-2941-2024
- **Recalling firm:** ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-04
- **Report date:** 2024-09-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Laval, Canada

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2941-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2941-2024. Source: US FDA. Licensed CC0.

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