NuVasive Stryde stopped shipping

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So do we have any news from the FDA's meeting with Nuvasive?

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Quote from: pownzorgeek on February 19, 2021, 12:41:54 PMSo do we have any news from the FDA's meeting with Nuvasive?

Offical update will be tomorrow according to Debiparshad after my consult with him a few days ago. He said it’s likely going to be officially recalled but their not sure of timelines so the update tomorrow should provide some info on that. Stryde in Europe is likely to come back in August or later and the US will be the first country to get it back he suspects.

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Quote from: RB on February 19, 2021, 12:58:15 PMOffical update will be tomorrow according to Debiparshad after my consult with him a few days ago. He said it’s likely going to be officially recalled but their not sure of timelines so the update tomorrow should provide some info on that. Stryde in Europe is likely to come back in August or later and the US will be the first country to get it back he suspects.

inb4 stryde gets delayed for even longer.

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My husband and I talked to the regional Sales Rep about Stryde. He said the independent company is doing testing and it is time consuming. He told us it will most likely be available by July 2021.

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Hi guys long time lurker, I was scheduled to have surgery next week, but my doctor just informed me that they are officially pulling Stryde from the market. It's a complete international recall according to him. No one will legally be able to use Stryde starting this Monday. He expects it to be longer than a year until changes are made and Stryde can come back to the market.

The recall is due to a small amount of corrosion that may occur with the nail while implanted.

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Jesus, can we please get some clarity on this matter. I really Hope it won’t  take a full year and they’ll get done by the end of the year at least. my surgery also got cancelled 1 week beforehand because of this mess.

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Well said, Siegfried. What a mess! I was hoping to pull the trigger in March but hadn’t actually scheduled anything yet. Sorry about your cancellation and all the other LLers who had their surgeries actually cancelled.  That sucks!

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Are there any official statements? I can't find any...

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FDA is jammed baked with new covid tech, its the only reason why the review assessment is taking so long.

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I don’t think the fda has any role to play here. This seems to be an internal testing study, which they failed to deliver in the past and which got uncovered by the nhs. As far as I understand there is no external agency involved here. The fda does also not play a role in Europe. But this is all speculation, since nuvasive has failed to deliver an official press statement to this day.