Limb Lengthening Forum
Limb Lengthening Surgery => Limb Lengthening Discussions => Topic started by: RB on February 04, 2021, 07:11:41 AM
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So according to several doctors, Nuvasive will be meeting with the FDA on the 9th of Feb to discuss if stryde will be recalled from the US market.
Its hard to speculate but what do you guys think the chances are that they agree to let surgeons use current stryde stock? What do you think will be discussed in the meeting?
And if stryde is taken off until the end of the investigation, what do you think these doctors will use as an alternative method?
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So according to several doctors, Nuvasive will be meeting with the FDA on the 9th of Feb to discuss if stryde will be recalled from the US market.
Its hard to speculate but what do you guys think the chances are that they agree to let surgeons use current stryde stock? What do you think will be discussed in the meeting?
And if stryde is taken off until the end of the investigation, what do you think these doctors will use as an alternative method?
What doctors? Have any sources besides just claiming it?
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What doctors? Have any sources besides just claiming it?
Yes, I have emailed Mahboubian and Debiparshad and these are the responses I got:
Debiparshad
Yes, everything is being presented to the FDA here for the US. MHRA guidelines in the UK are different from our FDA. The product was taken off the market in the UK and Ireland and now, I believe Internationally because of a gap in material testing and lack of testing in pediatric use. We currently are still able to book surgeries.
Mahboubian
Thanks for reaching out. There is an internal audit for their company, and we are waiting to hear back from the company by next week sometime. We will let you know when we have further information about this. Thank you!!
Another user on here also emailed Assayag and got a similar response.