FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Reported: September 4, 2024 Initiated: July 4, 2024 #Z-2941-2024
Product Description
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
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.
Details
- Recalling Firm
- ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
- Units Affected
- 6 units
- Distribution
- Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
- Location
- Laval
Frequently Asked Questions
What product was recalled? ▼
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System. Recalled by ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL. Units affected: 6 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2024. Severity: Moderate. Recall number: Z-2941-2024.
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