FDAFDA · Food and drugs·Recall number Z-2941-2024
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Published September 4, 2024 · Recall initiated: July 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
- Distributor
- Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
- Lot
- Part Number FRT250; Lot Numbers: F281-04, F462-02
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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