Reported Sep 4, 2024 · Ongoing

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

ORTHOPEDIATRICS CANADA ULC dba PEGA MEDICAL

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL · 1111 Chomedey (A-13) E · Laval · N/A

Is this the product you have?

  • FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Lot codes and dates
  • Part Number FRT250
  • Lot Numbers
    • F281-04
    • F462-02
Amount recalled
6 units

Where it was sold

  • Nationwide
  • TX

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.