FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Class I - Dangerous 🏥 Medical Devices
Recalled: July 4, 2024 ORTHOPEDIATRICS CANADA ULC Other Medical Devices
Nationwide
What Should You Do?
- Check if you have this product: Part Number FRT250; Lot Numbers: F281-04, F462-02
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Product Codes/Lot Numbers:
Part Number FRT250; Lot Numbers: F281-04, F462-02
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2941-2024