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Recall Observatory FDA recall evidence

Device product

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

Z-2941-2024

July 04, 2024

Class II

Product summary

Firm
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
Event
Event 95077
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-2941-2024

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.