Topic: Precice has also been recalled (Read 4901 times)

V21 · « **Reply #62 on:** April 27, 2021, 07:29:56 AM »

All Nuvasive and Giotikas said was that Precice would come back around July, nothing about Stryde. So I don't think Stryde is coming back that soon, there has been no news on that regard

Siegfried · « **Reply #63 on:** May 22, 2021, 03:42:13 PM »

Is there an update on when Precise two will return in europe?

V21 · « **Reply #64 on:** May 22, 2021, 03:49:04 PM »

Quote from: Siegfried on May 22, 2021, 03:42:13 PM

Is there an update on when Precise two will return in europe?

Two weeks ago everyone was 100% sure it would be back soon. Even the Nuvasive guy who answered my email said "definitely sooner than september". However, I asked yesterday with other accounts and all answers were much more random, like "we don't have a date". A few doctors told me they are not booking surgeries before september just in case. I don't like the tone this is getting compared with a few weeks ago. My surgery is booked for late August, and Precice is now available in all the world except in the EU, so one thinks it should not take long...

2020hope · « **Reply #65 on:** May 22, 2021, 04:27:37 PM »

They are probably studying the rare earth magnet in the nail. I think it hasn't been studied before.

V21 · « **Reply #66 on:** May 22, 2021, 07:02:54 PM »

Quote from: 2020hope on May 22, 2021, 04:27:37 PM

They are probably studying the rare earth magnet in the nail. I think it hasn't been studied before.

But it's incredibly bad luck that it's available everywhere but in the EU. My surgery has already been moved twice lol. Just hope it will be back August-September

Arcon · « **Reply #67 on:** May 23, 2021, 05:12:52 AM »

Quote from: V21 on May 22, 2021, 07:02:54 PM

But it's incredibly bad luck that it's available everywhere but in the EU...

They stopped shipping everywhere, not only Europe.

Worzezterlire · « **Reply #68 on:** May 23, 2021, 05:56:15 AM »

Quote from: Arcon on May 23, 2021, 05:12:52 AM

They stopped shipping everywhere, not only Europe.

I know US surgeons are still performing and scheduling Precise 2.2 surgeries, mine is in 3 weeks. Hopefully it won’t be rescheduled but if it is, beats waiting a year for Stryde. I have a call with the office tomorrow and if mine is rescheduled I’ll post here (if not then I probably won’t which you can take as meaning that precise is available right now)

V21 · « **Reply #69 on:** May 23, 2021, 06:14:51 AM »

Quote from: Arcon on May 23, 2021, 05:12:52 AM

They stopped shipping everywhere, not only Europe.

The doctors I have emailed say that the issue has been quickly resolvend in US and India. So Precice is being already shipped to all those places... and not to Europe until they get CE mark back

2020hope · « **Reply #70 on:** May 23, 2021, 06:47:33 AM »

Quote from: V21 on May 23, 2021, 06:14:51 AM

The doctors I have emailed say that the issue has been quickly resolvend in US and India. So Precice is being already shipped to all those places... and not to Europe until they get CE mark back

Which doctor told you about India?

I don't think you have an option but to wait dude. US is too expensive and I don't think it's safe to enter India. Or you can RB's route and get it done with Betz. Or external tibias.

V21 · « **Reply #71 on:** May 23, 2021, 10:03:04 AM »

Quote from: 2020hope on May 23, 2021, 06:47:33 AM

Which doctor told you about India?

I don't think you have an option but to wait dude. US is too expensive and I don't think it's safe to enter India. Or you can RB's route and get it done with Betz. Or external tibias.

Parihar said Precice is available there. I have no choice but to wait, I already paid deposit for Greece. The thing is that the surgery was delayed to late August, and I'm freaking out about Precice not being back by then. I can't aford betzbone either

V21 · « **Reply #72 on:** June 11, 2021, 05:51:24 AM »

Guys, thing are again getting slowly delayed. In May I was told that Precice would be back on July-August. Now I got this message:

"Thank you for your email. In their update on the 8th June, the manufacturer said that Precise-2 is expected back in September 2021 sometime. The next update will be on the 29th June. We remain at your disposal for any further information and assistance".

This is crazy man. If it gets delayed later than September, I would have to wait until December, and it seems like that is what is going to happen.

Siegfried · « **Reply #73 on:** June 11, 2021, 06:05:02 AM »

Yeah what nuvasive has been pulling of this year is ridiculous. They can be happy there is no competition on the market yet.

V21 · « **Reply #74 on:** June 11, 2021, 06:40:45 AM »

But Precice it's already available everywhere else. It's crazy Europe is taking that long.

Arcon · « **Reply #75 on:** June 11, 2021, 03:09:46 PM »

Quote from: Serilium on April 23, 2021, 06:03:37 PM

Lon tibia only

No recommendation for femur

LATN better than LON for bone infection.. Not for femurs, I agree.

V21 · « **Reply #76 on:** June 14, 2021, 09:15:23 AM »

Hey guys, more news. The nuvasive european representative said this:

"From what we know today, September should be the very latest moment for the return of Precice.

We all assume a much earlier return, but the final decision is with the authorities and therefore we cannot say with any certainty when the authorities will have completed their internal work.

Since we do not want to risk any further delays, we have not communicated an earlier date"

Arcon · « **Reply #77 on:** June 14, 2021, 10:31:45 AM »

Quote from: V21 on June 14, 2021, 09:15:23 AM

Hey guys, more news. The nuvasive european representative said this:

"From what we know today, September should be the very latest moment for the return of Precice.

We all assume a much earlier return, but the final decision is with the authorities and therefore we cannot say with any certainty when the authorities will have completed their internal work.

Since we do not want to risk any further delays, we have not communicated an earlier date"

That's useful and sounds promising. Thanks for sharing!

V21 · « **Reply #78 on:** June 14, 2021, 01:08:25 PM »

Quote from: Arcon on June 14, 2021, 10:31:45 AM

That's useful and sounds promising. Thanks for sharing!

I can wait at worst until september, so I'm crossing my fingers lol.

Siegfried · « **Reply #79 on:** June 14, 2021, 01:54:40 PM »

Bureaucracy in the EU has always been a problem, so I’m not surprised that it’s already available everywhere else.

V21 · « **Reply #80 on:** June 30, 2021, 06:19:51 AM »

New update from Giotikas:
"Thank you for your email. The update of the 28th June said that they are on good track for the return of Precise-2 nail until late August 2021 or early September"
Being two months away, I'm somewhat hopeful it's true or that at worst precice will be back late september.

V21 · « **Reply #81 on:** July 20, 2021, 02:07:21 PM »

New update from Giotikas today:
Thank you for your email. The update from Nuvasive today said that everything is ready and they are just awaiting the official announcement from the EMA (the FDA equivalent in EU). Obviously they cannot control the timing but it should be by the second half of August or Early September at the latest. They are preparing their production line for Precise-2 nails, according to the pre-orders they have (yours included!). The next update will be on the 29th July.

We remain at your disposal for any further information and assistance

SpeedDialer · « **Reply #82 on:** August 18, 2021, 07:11:28 PM »

Hm... does this affect us if we want to do LL in say late 2022/early 2023? Is it likely precise and stryde will be back?

Siegfried · « **Reply #83 on:** August 18, 2021, 07:24:52 PM »

Limb Lengthening Forum

Author Topic: Precice has also been recalled (Read 4901 times)