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Author Topic: Precice has also been recalled  (Read 4912 times)

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Stretch

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Re: Precice has also been recalled
« Reply #31 on: April 23, 2021, 06:05:02 PM »

Opinions from other surgeons would be useful in order to know if we can expect precice back soon

True
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Stretch

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Re: Precice has also been recalled
« Reply #32 on: April 23, 2021, 06:11:59 PM »

Lon tibia only

No recommendation for femur

I do hear this frequently throughout the forum. However I also read of patients achieving their LL goals with LON Femur, so i'm like wtf?
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Body Builder

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Re: Precice has also been recalled
« Reply #33 on: April 23, 2021, 07:16:59 PM »

Dude, I'm devastated. I had surgery booked for 23 june with Precice.
Giotikas sends this today https://www.athensbjr.com/update-on-the-nuvasive-specialized-orthopedics-precice-device-system/

I think I am going to have to do externals, since I just want 5 cm. Please, can someone give advice?
Go for externals.
It is the safest and less painful way of doing LL and for only 5cm you won't have much time the frames and the cost will be half of precise.
For me, even if precise-stryde were in market, I would still have gone for pure externals if I wanted only one LL.
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V21

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Re: Precice has also been recalled
« Reply #34 on: April 23, 2021, 07:26:03 PM »

Go for externals.
It is the safest and less painful way of doing LL and for only 5cm you won't have much time the frames and the cost will be half of precise.
For me, even if precise-stryde were in market, I would still have gone for pure externals if I wanted only one LL.
I see your point but I can't be months and months with the frames because of my circunstances, so I would have to do LATN, not pure externals. I would very much prefer 5 cm on femurs, which is a very very safe amount on that segment. Anyway, on Monday Giotikas will evaluate my proportions, if I'm measuring correctly my Tibia/femur ratio is 36/45-46
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RealLostSoul

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Re: Precice has also been recalled
« Reply #35 on: April 23, 2021, 07:26:29 PM »

I
Ahh pissed precise is now gone  :(

Correct me if wrong, So as it stands now the methods available for cosmetic LL are:

Guichet nail
Beztbone
LON
LATN

What would be the preferred choice for femur or Tibia. Taking into consideration the cost, reliability and successful patient outcomes?

For femur I think betzbone is reasonable. There are a lot of good diaries with betzbone in the last years. About guichet idk. LON and LATN for femur, don‘t. For Tibia I‘d say wait for STRYDE or LON.
Just my two cents about it/
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Serilium

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Re: Precice has also been recalled
« Reply #36 on: April 23, 2021, 07:31:17 PM »

Go for externals.
It is the safest and less painful way of doing LL and for only 5cm you won't have much time the frames and the cost will be half of precise.
For me, even if precise-stryde were in market, I would still have gone for pure externals if I wanted only one LL.

5cm externals will be anywhere from a best case scenario 7.5months to a more realistic 9-10 months in frames. All for 5cm. That is alot of time in frames it's not short at all
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RealLostSoul

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Re: Precice has also been recalled
« Reply #37 on: April 23, 2021, 07:36:08 PM »

5cm externals will be anywhere from a best case scenario 7.5months to a more realistic 9-10 months in frames. All for 5cm. That is alot of time in frames it's not short at all

yes true, only externals is very tough mentally. If you can deal with that go for it (plus you only need 1 surgery right?)
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V21

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Re: Precice has also been recalled
« Reply #38 on: April 24, 2021, 07:07:52 AM »

I have been told that Rozbruch and the doctors on the Poland Paley Institute also seem very confident that Precice will be back soon: june in the US and july in the EU. Just hope it's true, any info from your doctos would be much appreciated.
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6CMFemurs

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Re: Precice has also been recalled
« Reply #39 on: April 24, 2021, 08:53:01 AM »

Wait so the old school titanium precise is off the market in the US now too? Haven't they ton like thousands of lengthenings over 10 years with it already?
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V21

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Re: Precice has also been recalled
« Reply #40 on: April 24, 2021, 08:55:28 AM »

Wait so the old school titanium precise is off the market in the US now too? Haven't they ton like thousands of lengthenings over 10 years with it already?
The product lost the CE mark, and in the rest of the world the suspension is voluntary until all is solved. However, everyone seems to say it will be solved soon... I hope it's true, don't want to do tibias.
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Body Builder

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Re: Precice has also been recalled
« Reply #41 on: April 24, 2021, 12:29:21 PM »

5cm externals will be anywhere from a best case scenario 7.5months to a more realistic 9-10 months in frames. All for 5cm. That is alot of time in frames it's not short at all
The average time you need for 1cm LL from surgery till frame removal is 40 days.
So no, 5cm don't need realistically 10 months but 7-7,5 at max for an average person.

I needed 11 months for 7.5 cm after all which is 50% more than 5cm and the more you lengthen the more the rehabilitation is.

So the difference between lon and pure externals is about 4 months without ilizarov in your feet.
But you'll have a less invasive surgery, no nail removal surgery (which is a major surgery too), you'll need less money and it is safer and less painful.
So for me it is easily a far preferable choice than lon or latn for only 5cm.
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RealLostSoul

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Re: Precice has also been recalled
« Reply #42 on: April 24, 2021, 02:02:53 PM »

The average time you need for 1cm LL from surgery till frame removal is 40 days.
So no, 5cm don't need realistically 10 months but 7-7,5 at max for an average person.

I needed 11 months for 7.5 cm after all which is 50% more than 5cm and the more you lengthen the more the rehabilitation is.

So the difference between lon and pure externals is about 4 months without ilizarov in your feet.
But you'll have a less invasive surgery, no nail removal surgery (which is a major surgery too), you'll need less money and it is safer and less painful.
So for me it is easily a far preferable choice than lon or latn for only 5cm.

Out of curiosity, how big of an event is the removal of externals? Is it under local anesthesia, how long does it take, etc. ?
And would you say 7.5cm with pure externals is feasible or did you push it too much?
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10cmOnTibiaOrGTFO

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Re: Precice has also been recalled
« Reply #43 on: April 24, 2021, 10:09:57 PM »

dude just buy precice nail off of aliexpress and give it to your surgeon
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FormerKidd

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Re: Precice has also been recalled
« Reply #44 on: April 25, 2021, 03:40:38 AM »

Wait so the old school titanium precise is off the market in the US now too? Haven't they ton like thousands of lengthenings over 10 years with it already?

Precice is Titanium and Stryde is... Steel?

Is that why my Precice rods never set metal detectors, but the Stryde ones usually do?

(Nevertheless, I guess I need to get these removed pronto.)
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SpeedDialer

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Re: Precice has also been recalled
« Reply #45 on: April 25, 2021, 03:51:34 AM »

Ahhh.....

So no stryde either I imagine?
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Serilium

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Re: Precice has also been recalled
« Reply #46 on: April 25, 2021, 03:59:02 AM »

Precice is Titanium and Stryde is... Steel?

Is that why my Precice rods never set metal detectors, but the Stryde ones usually do?

(Nevertheless, I guess I need to get these removed pronto.)

Stryde is stainless steel yeah
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Serilium

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Re: Precice has also been recalled
« Reply #47 on: April 25, 2021, 04:01:10 AM »

Ahhh.....

So no stryde either I imagine?

seems like you took a hiatus for a bit and missed out on alot. In February this year a doctor reported Stryde nails to european health committee after observing corrosion and
 thus Stryde has a corrosion scandal that was happening in many many patients and was recalled by nuvasive worldwide and is now not allowed to be used until they bring it back which is probably next year.

they are probably going to redesign the nail

precice was also temporarily banned at first but lifted in certain countries but not some countries in the EU. but now ce seal of precice is gone so i guess it's gone worldwide again.

as far as we know precice doesn't have any of these corrosion problems
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BelowTheMean

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Re: Precice has also been recalled
« Reply #48 on: April 25, 2021, 04:49:17 AM »

Precice is Titanium and Stryde is... Steel?

Is that why my Precice rods never set metal detectors, but the Stryde ones usually do?

(Nevertheless, I guess I need to get these removed pronto.)

My Stryde nails have never set off a metal detector and I've gone through airport security seven times since my surgery.
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Stryde Femurs - Debiparshad - Nov 2020
Nail Removal - Downey - Apr 2022
Journal (169cm -> 177cm) http://www.limblengtheningforum.com/index.php?topic=65617

Current Status: Recovered, moving on

V21

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Re: Precice has also been recalled
« Reply #49 on: April 25, 2021, 07:17:33 AM »

What I don't understand is why they suspended Precice again. FDA said all ok, and it was also used in Europe in March. I will ask Giotikas tomorrow, but this time everyone seems quite confident it will be solved soon
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10cmOnTibiaOrGTFO

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Re: Precice has also been recalled
« Reply #50 on: April 25, 2021, 04:30:40 PM »

What I don't understand is why they suspended Precice again. FDA said all ok, and it was also used in Europe in March. I will ask Giotikas tomorrow, but this time everyone seems quite confident it will be solved soon

Dont think so
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FormerKidd

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Re: Precice has also been recalled
« Reply #51 on: April 25, 2021, 07:19:18 PM »

My Stryde nails have never set off a metal detector and I've gone through airport security seven times since my surgery.

Interesting -- wonder if the femur/tibia difference could come into play?
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Jackieeechan

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Serilium

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Re: Precice has also been recalled
« Reply #53 on: April 26, 2021, 02:42:03 AM »

I think they are upgrading the precise with new screws

https://www.prweb.com/releases/diamond_orthopedic_announces_supply_agreement_with_nuvasive_specialized_orthopedics/prweb17653993.htm

That's not the precice rod used for adult stature lengthening. Thats the precice plate used for little kids, not relevant to the precice lengthening nail
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V21

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Re: Precice has also been recalled
« Reply #54 on: April 26, 2021, 08:56:04 AM »

I just talked to Giotikas. He advised me to wait for Precice, because he expects it to be back in july, or at worst on August. Of course, he can't guarantee it, but thinks it's very reasonable to book the surgery for 24 August.

Another representative from Nuvasive told me this:

"Thanks for your email.

 Yes, for me August sounds very realistic.

But as you know, I can’t guarantee you a specific date before all the work is done"
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curlyfella

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Re: Precice has also been recalled
« Reply #55 on: April 26, 2021, 03:32:53 PM »

Read online today that June is a possible date for stryde return.

any truth to this?
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las vegas baby

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Re: Precice has also been recalled
« Reply #56 on: April 26, 2021, 04:08:51 PM »

Read online today that June is a possible date for stryde return.

any truth to this?

name your source bruh
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V21

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Re: Precice has also been recalled
« Reply #57 on: April 26, 2021, 04:18:03 PM »

Read online today that June is a possible date for stryde return.

any truth to this?
Giotikas did not say anything about this, so I really doubt it. It does not make sense that precice won't be available until july-august but Stryde in june. I really doubt it
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curlyfella

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Re: Precice has also been recalled
« Reply #58 on: April 26, 2021, 11:00:11 PM »

Halil Buldu - said it.


I contacted manufacturer and they said its for precice most likely
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Going-For-Three

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Re: Precice has also been recalled
« Reply #59 on: April 26, 2021, 11:41:29 PM »

Giotikas did not say anything about this, so I really doubt it. It does not make sense that precice won't be available until july-august but Stryde in june. I really doubt it
They said the end of Q3, so June wouldn't be completely out of the realm of possibility.
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V21

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Re: Precice has also been recalled
« Reply #60 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
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Siegfried

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Re: Precice has also been recalled
« Reply #61 on: May 22, 2021, 03:42:13 PM »

Is there an update on when Precise two will return in europe?
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Unilateral Quadrilateral Lengthening 2021/22 w/ Koehne
Pre-Surgery: 1.67 m
Post-Surgery: 1.76 m
My Story: http://www.limblengtheningforum.com/index.php?topic=68285.msg221238#msg221238
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