ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL: Device Recall
Recall #Z-2941-2024 · 07/04/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2941-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
- Status
- Ongoing
- Date Initiated
- 07/04/2024
- Location
- Laval, Canada
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
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.
Product Description
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Distribution Pattern
Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.