FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Summary
The FDA issued a Class II for FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System by ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL. Reason: During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250.
Details
Source
Device Recall
External ID
Z-2941-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Lot/Code Info: Part Number FRT250; Lot Numbers: F281-04, F462-02
Quantity Affected: 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.
Distribution
Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-04
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL have FDA actions?
This is the only FDA action we have on record for ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2941-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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