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Re: There is NOT a recall!

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> Only that the FDA

> gave them approval for a limited number and is not processing their

requests

> for more until they get to very low levels remaining.

Does anyone understand what this bizarre process achieves, apart from

inconvenience? Is there any chance that permission for more will not

be granted (and if not, why impose the limit)?

Good news that there is no technical problem.

Vale

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I'm not stupid, but what exactly does this mean? Those of us with

surgery dates surely would have been notified by now if there has

been a delay of some sort. More info please??????

> > > > I just got a call from my Doctor's office saying there has

been a

> > > > recall on the resurfacing device from . Claims may be

> > > > available in 45 days. Does anyone know why?

> > > >

> > > > Thank you,

> > > > Ray

> > >

> > > - who is your Doctor??? Deb

> >

> > He is T. Vail out of Duram, NC. Also, I forgot to state

that

> > is was a FDA recall.

> >

> >

> >

> >

> >

> >

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Is your surgery in the next 6 weeks or so and with a Conserve Plus doc (not

Corin?)?

From reports here, the phone calling to reschedule, etc, only started today,

so

your bad news may come from your surgeon tomorrow or later. News travels

fast on the internet, faster than people can call weeks-worth of patients.

My surgery was delayed two weeks from its original schedule due a different

sort of scheduling problem -- fortunately for me I found out soon enough I

had not made travel arrangements, etc (due to insurance concerns I was being

very conservative about that, anyway). I was a little disappointed - I was

getting impatient by then - but it all worked out OK in the long run.

-

> Re: There is NOT a recall!

>

>

> I'm not stupid, but what exactly does this mean? Those of us with

> surgery dates surely would have been notified by now if there has

> been a delay of some sort. More info please??????

>

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God Bless you, !! My 3-week C+ hip and I will sleep well

tonight :) and I'll say prayers for all the folks whose surgery dates

just got messed up....... Deb

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> > > > > I just got a call from my Doctor's office saying there has

> been a

> > > > > recall on the resurfacing device from . Claims may be

> > > > > available in 45 days. Does anyone know why?

> > > > >

> > > > > Thank you,

> > > > > Ray

> > > >

> > > > - who is your Doctor??? Deb

> > >

> > > He is T. Vail out of Duram, NC. Also, I forgot to state

> that

> > > is was a FDA recall.

> > >

> > >

> > >

> > >

> > >

> > >

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Yep~ July11th~ Dr. Mont

>

> Is your surgery in the next 6 weeks or so and with a Conserve Plus

doc (not

> Corin?)?

>

> From reports here, the phone calling to reschedule, etc, only

started today,

> so

> your bad news may come from your surgeon tomorrow or later. News

travels

> fast on the internet, faster than people can call weeks-worth of

patients.

>

> My surgery was delayed two weeks from its original schedule due a

different

> sort of scheduling problem -- fortunately for me I found out soon

enough I

> had not made travel arrangements, etc (due to insurance concerns I

was being

> very conservative about that, anyway). I was a little

disappointed - I was

> getting impatient by then - but it all worked out OK in the long

run.

>

> -

>

> > Re: There is NOT a recall!

> >

> >

> > I'm not stupid, but what exactly does this mean? Those of us with

> > surgery dates surely would have been notified by now if there has

> > been a delay of some sort. More info please??????

> >

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At 10:12 PM 5/23/2002 +0000, you wrote:

>Does anyone understand what this bizarre process achieves, apart from

>inconvenience? Is there any chance that permission for more will not

>be granted (and if not, why impose the limit)?

Because these devices are not yet fully approved, they have to go through

the protocol. I'm sure there have to be quotas such as they have done in

allowing continued access--if not, it would be nearly the same thing as

full approval. Imagine if it turned out that they allowed full access to

something prior to the final approval and it turned out to be a complete

failure...

I am glad to see that they have allowed continued access as they have-bodes

well for the approval, but it is too bad someone wasn't aware earlier just

how quickly the allotment was being used up.

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At 04:49 PM 5/23/2002 -0500, you wrote:

>Although it cannot alert us to all potential problems, one reason I started

>this forum was to be able to catch any trends (good or bad) that might be

>seen in the patient population because this should be the quickest way to

>spot them, rather than waiting on the regulators, companies or surgeons to

>tell us.

And I for one, will be eternally grateful for the information I have

received (and continue to) from this group. If not for Totally Hip and

being led to this group, I would certainly have already had or have been

seriously looking at THR. I put off surgery as long as I did because I SO

did not want THR.

Thank you !!!!!

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