Quote from: smalltaller on February 20, 2021, 05:31:42 AMAre there any official statements? I can't find any...
Here’s the official documentation regarding the recall.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=86150
Quote from: osiris on February 20, 2021, 09:23:58 AMHere’s the official documentation regarding the recall.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=86150
That is not the correct recall documentation or link. That is not the stryde or precice stature lengthening nail. That is a recall for a limb Salvage nail called a bone transport nail. (Which was actually also recalled along with stryde this month as well) Different and was months ago in October . Unrelated am sorry
Toxicity assessments is expected to be completed in Q2 2021. Stryde may be put on market after this tests . s . Really sorry to everyone who want suregery
Stryde is product pulled because of report of bony abnormality on side of extending (telescoping) part of the nail . Perhaps risk no good need further test t.
Nuvasive personal recall document 200+ pages only first few are relevant
https://mhra-gov.filecamp.com/s/pz82Q5uAZowsRb7s/d
Quote from: ghkid2021 on February 20, 2021, 10:19:35 AMToxicity assessments is expected to be completed in Q2 2021. Stryde may be put on market after this tests . s . Really sorry to everyone who want suregery
Even Nuvasive is saying now July at the earliest, so definitely no quarter 2 
Quote from: Siegfried on February 20, 2021, 07:12:55 AMI 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.
You are true. That's just negligence by the company.
worst part is no communication even now!!
there needs to be a PRESS RELEASE with a public apology at this point!!
Quote from: V21 on February 20, 2021, 10:36:32 AMEven Nuvasive is saying now July at the earliest, so definitely no quarter 2
End of June is considered q2
Yah FDA did not issue a recall this is nuvasive themself
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