FRT250 Telescopic Implant Cartridge Recalled for Component Substitution
OrthoPediatrics Canada is recalling FRT250 cartridges used in the Fassier-Duval Telescopic IM System because an incorrect component was substituted during assembly.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II device with a manufacturing defect involving component substitution in an orthopedic implant system. Although no injuries have been reported, the substitution of a critical component in a risk-of-harm implant device represents a material safety concern.
Plain-English summary
OrthoPediatrics Canada ULC, doing business as Pega Medical, is recalling FRT250 cartridges that are components of the Fassier-Duval Telescopic IM System. A total of 6 units were affected.
During assembly of the FRT250 cartridge, an incorrect component was used. Specifically, the FRT240-HEX was used instead of the correct FRT250-HEX component.
The recalled cartridges were distributed worldwide, including in the United States (Texas), United Arab Emirates, Brazil, Canada, and the Netherlands. The affected lot numbers are F281-04 and F462-02. This is a Class II recall issued by the FDA.
The recalled product
- Product
- FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
- Manufacturer
- ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
- Hazard
- component-substitution
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part Number FRT250
- Lot Numbers: F281-04
- F462-02
Distribution
Distributed nationwide across the United States.
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