FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
This recall is currently active, issued August 29, 2024. It was issued by Orthopediatrics Canada Ulc Dba Pega Medical 1111 Chomedey (A-13) E Laval Canada.
- Recall Initiated
- July 4, 2024
- Posted
- August 29, 2024
- Recall Number
- Z-2941-2024
- Quantity
- 6 units
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Part Number FRT250; Lot Numbers: F281-04, F462-02
Root Cause
Process control
Action Taken
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.