ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL: Medical Device Recall in 2024 - (Recall #: Z-2941-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 4, 2024

Date Posted: September 4, 2024

Recall Number: Z-2941-2024

Event ID: 95077

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.

Status: Ongoing

Product Quantity: 6 units

Code Information:

Part Number FRT250; Lot Numbers: F281-04, F462-02

Distribution Pattern:

Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated