FRT250 - 4.0-6.4 CARTRIDGE. Component of the recall
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Why was FRT250 - 4.0-6.4 CARTRIDGE. Component of the 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number FRT250; Lot Numbers: F281-04, F462-02
- Product
- FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
- Recalling firm
- ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
- Quantity
- 6 units
- Distribution
- Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
- Recall date
- September 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)