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
F281-04F462-02
- 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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