Z-2941-2024Class II

FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System

Name: Z-2941-2024 FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Creator: ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
Published: 2024-07-04
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2024-07-04 / Open, Classified / root cause: manufacturing process

FDA source

ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL began a recall of FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System on 2024-07-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2941-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-04
Posted: 2024-08-29
Recalling firm: Orthopediatrics Canada ULC
Product: FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On about 07/04/2024, Orthopediatrics notified consignees via email. Consignees were instructed to identify any affected units and spare parts within inventory, contact Customer Service, and arrange for return of affected units. Consignees were also instructed to notify all applicable personnel or customers if further distributed or transferred.
Quantity in commerce: 6 units
Distribution: Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
Product codes and lots: Part Number FRT250; Lot Numbers: F281-04, F462-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2941-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2941-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-29

Product code LXH

K041393Class IIFassier-Duval Telscopic Im SystemPega Medical, Inc. / cleared 2004-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)