OrthoPediatrics Canada (Pega Medical) is recalling 6 units of the FRT250 4.0-6.4 Cartridge, which is a component of the Fassier-Duval Telescopic IM System. During manufacturing, an incorrect hex component (FRT240-HEX instead of FRT250-HEX) was used during assembly. This recall affects two specific lots of the medical device component distributed in Texas and several other countries.
The use of an incorrect hex component in the cartridge assembly can lead to mechanical failure or improper fit during surgical procedures involving the Telescopic IM System. This defect could potentially cause surgical delays or require revision surgery if the error is not identified before or during implantation.
Manufacturer notification and return
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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