Class 2 Device Recall FassierDuval Telescopic IM System

• Date Initiated by Firm: July 04, 2024
• Date Posted: August 29, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2941-2024
• Recall Event ID: 95077
• 510(K)Number: K041393
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
• Code Information: Part Number FRT250; Lot Numbers: F281-04, F462-02
• Recalling Firm/ Manufacturer: ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL; 1111 Chomedey (A-13) E; Laval Canada
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LXH