FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
FDA Recall Z-2941-2024 · Posted 2024-08-29
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Recalling FirmORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
Recall StatusOpen, Classified
Product CodeLXH
Date Initiated2024-07-04
Product Quantity6 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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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