New Challenge for Nobel Reps

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Anonymous said:
Past recalls have nothing to do with the present mess.Unlike previous issues, if this is legit it affects every single Nobel implant on the planet. Why did they not put a 1 penny washer in the vial just like Niznick told them to do a couple of years ago? THE SILENCE AND DISCUSSIONS ABOUT PREVIOUS RECALLS RATHER THAN THE PRESENT PROBLEM SCREAMS "WE HAVE SCREWED UP"!
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This is no big deal at all so relax dude. Nothing is going to come out of it.
 




Anonymous said:
The "recalls" you cite are administrative recalls that had zero effect on the companies revenue or patient's health.
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Any company can mislabel a length of implant or put the wrong screw in the vial, and then deal with it by a recall with some short term embarresment. The situation here is that Nobel's Information for Use that accompanies every implant sale states "Do not use implants if the packaging has been damaged or previously opened" and only "use prior to the labelied expiration date." If their sterile implant vials leak, as they appear to, then their own labeling indicates that you should not use them. Mosher can say all the platitudes he wants about Nobel's high standards of quality control, but he has not addressed the fundimental question of what the difference is between an implant claiming to be sterile while not being in an airtight sealed container, and an implant that has been opened which Nobel warns dentists not to use.
 








Anonymous said:
Does anyone find irony in the fact that at the bottom of the page there is a recall add for Zimmer hip replacements?

Just an observation
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This ad is by attornies looking for clients to sue Zimmer for the recall. How long do you think it will take the lawyers to start advertising for patients who had failed Nobel Biocare implants? Dow Corning that sold silicon breast implants, made a $2.3B settlement to a class action law suit after filing Chapter 11 Bankruptcy - and the FDA never issued a recall. What can be worse than selling implants in leaking vials while claiming sterility?
 




Anonymous said:
Anyone remember Dow Corning? $3.2B Class Action settlement, Bankruptcy - and the FDA never issued a recall on their silicon breast implants. Wait until the PI attornies get a hold of this. They will be advertising on TV for anyone who had a failure with Nobel Implants, and any doctors who place them after reading the reports posted on Implant Direct's website could be named also. This could be a game changer. Nobel may not be able to put Humpty Dumpty back to gether again. Every rep for a competing company will be talking about it and the Nobel reps will be so busy deflecting questions and returns, they won't have time to negotiate discounts.
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I´m a spanish Nobel Rep and I don´t need time to negotiate discounts. Yes I´m very busy, busy selling cutting-edge solutions and products....Seems you dont do this, seems you only negotiate discounts....sorry for you!
 




Anonymous said:
I´m a spanish Nobel Rep and I don´t need time to negotiate discounts. Yes I´m very busy, busy selling cutting-edge solutions and products....Seems you dont do this, seems you only negotiate discounts....sorry for you!
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Hola!
Imagine how busy you will be negotiating if you have to take all your product back!
Will the next ISO inspector just ignore a leak test?
You are a hard working person and I hope you will not be disappointed by the support you will get from the mothership if things are not going so well.
 








Hmmm

http://www.hc-sc.gc.ca/dhp-mps/comp...rec-ret_md-im_manu-fab_july-sept_2009-eng.php

Manufacturer Implant Direct LLC
Recall Posting Date 2009-09-14
Trade Name A) Screwplant Implants
B) Screwplant Healing Collars
C) Legacy Healing Collars
D) Screwindirect Implants
E) Screwplus Implants
F) Screwdirect Implants
G) Replant Implants
H) Replus Implants
Recall Start Date 2009-08-18
Recall Number 50598
Hazard Classification Type II
Model or Catalog # A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A
H) N/A
Lot or Serial # A) > 100 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer
C) > 10 Numbers, Contact Manufacturer
D) > 10 Numbers, Contact Manufacturer
E) > 10 Numbers, Contact Manufacturer
F) > 10 Numbers, Contact Manufacturer
G) > 10 Numbers, Contact Manufacturer
H) > 10 Numbers, Contact Manufacturer
Reason for Recall Cover caps exhibited visible cracks post sterilization.
 




Hmm

http://www.hc-sc.gc.ca/dhp-mps/comp...rec-ret_md-im_manu-fab_july-sept_2009-eng.php

Manufacturer Implant Direct LLC
Recall Posting Date 2009-09-14
Trade Name A) Screwplant Implants
B) Screwplant Healing Collars
C) Legacy Healing Collars
D) Screwindirect Implants
E) Screwplus Implants
F) Screwdirect Implants
G) Replant Implants
H) Replus Implants
Recall Start Date 2009-08-18
Recall Number 50598
Hazard Classification Type II

Reason for Recall Cover caps exhibited visible cracks post sterilization.
 




Maybe this thread should be called "new challenge for Implant Direct reps" since it looks like they have a whole bunch of serious recalls that could endanger their patients, and cause bacteria to get inside their packaging. This is is some turn of events. This recall is official, and not fabricated by Nobel, since it was mandated by the Canadian Government. All the Nobel reps in both countries have been briefed on how to react to IP misinformation campaign if it ever comes up in discussion with the doctors. So far nothing. It is ironic that Niznick's attempt to discrediting Nobel's reputation has only creates an even lower level of credibility for Niznick's company.
 




Anonymous said:
Hmm

http://www.hc-sc.gc.ca/dhp-mps/comp...rec-ret_md-im_manu-fab_july-sept_2009-eng.php

Manufacturer Implant Direct LLC
Recall Posting Date 2009-09-14
Trade Name A) Screwplant Implants
B) Screwplant Healing Collars
C) Legacy Healing Collars
D) Screwindirect Implants
E) Screwplus Implants
F) Screwdirect Implants
G) Replant Implants
H) Replus Implants
Recall Start Date 2009-08-18
Recall Number 50598
Hazard Classification Type II

Reason for Recall Cover caps exhibited visible cracks post sterilization.
Click to expand...

Were waiting Jerry...
 








This seems like a very serious issue for patients and doctors who are using Implant Direct products. If there is a breach in the packaging of Implant Direct implants, no one can certify that the implants are in fact sterile as claimed by the company. Apparently Niznick is cutting corner in more areas than just the sales department. Selling contaminated implants is a serious violation of both the law and trust. All patients who have had an Implant Direct implant placed and have experienced a failure should notify their attorney quickly. This will soon be a class action lawsuit.
 




Only Niznick would call Nobel out on an issue with the FDA and sterility then to find out ID has an issue. It is almost like he was creating a smokescreen for his own issues. Just how ignorant was that move. He looks like a complete idiot! And you don't think Nobel will be dropping a dime on him with the FDA. The implant biz continues to amaze.
 




Lets call a spade a spade here. Niznick, may know metallurgy and thread design, but he is an idiot when it comes to public relations and marketing. This is a classic example of stepping on one's own cock. Comical for sure. Idiotic, pathetic and ironic. Now the shit bag is no where to be seen. What will be most comical is how he will attempt to defend this serious breach of the law. Most likely he will blame Nobel for HIS packaging non compliance. He will say it is only the Canadian regulatory agency that has the issue, and that the US FDA is less strict, therefore not its not really an issue in the US. Let's see what this irrelevant desperate old man comes up with in response. Sometimes you need to let lying dogs lie. Niznick needs to understand this. Nobel has a much more educated, better financed team that this Niznick does. This whole thing is one of the funniest blunders I have seen in the business world. It shows sometimes people have more money than brains.
 




Anonymous said:
Maybe this thread should be called "new challenge for Implant Direct reps" since it looks like they have a whole bunch of serious recalls that could endanger their patients, and cause bacteria to get inside their packaging. This is is some turn of events. This recall is official, and not fabricated by Nobel, since it was mandated by the Canadian Government. All the Nobel reps in both countries have been briefed on how to react to IP misinformation campaign if it ever comes up in discussion with the doctors. So far nothing. It is ironic that Niznick's attempt to discrediting Nobel's reputation has only creates an even lower level of credibility for Niznick's company.
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YES, a leaking implant vial could cause bacteria to get inside and endanger patients.

NO, Implant Direct's implant vials with micro-cracks, removed from our inventory in August 2007 did not compromise the integrity of the seal of its sterile implant vials. This is well documented by the published leak tests done in 2007 and repeated in 2009 on the same vials. The results of these tests are posted on implant Direct's website at:
http://www.implantdirect.com/newsletter_0/newsletter_18/pdf/appendix5.pdf

YES, there is strong evidence now in the hands of Health Canada and the FDA that Nobel Biocare's Implant Vials, currently being sold as sterile, in fact fail the industry standard dye leak test conducted by an independent testing laboratory approved by the FDA.
http://www.implantdirect.com/newsletter_0/newsletter_18/pdf/appendix2_sm.pdf


Nobel Biocare, in an act of shear desperation, and without adequate consideration for the unintended consequences that would result, sought to exploit the cosmetic micro-crack incident two years after the fact as explained below in the Narrative filed with the FDA:
http://www.implantdirect.com/newsletter_0/newsletter_18/pdf/ReportNarrative_091809.pdf

Here is an excerpt of that Narrative:
"In June 2009, Implant Direct Canada demoted its Director of Operations, Ms.
Adele Fussi, to a sales position. She resigned and, while negotiating for a high
paying position with Nobel Biocare, reported Implant Direct to Health Canada
regarding a packaging issue that Implant Direct had experienced two years
earlier. This resulted in an inquiry by Health Canada that has since been
resolved. The packaging issue related to an August 2007 removal from inventory
of a small number of implants with a cosmetic, micro-crack in the cap. Implant
Direct, using standard leak tests conducted in August 2007 and again in July
2009 confirmed that these micro-cracks did not result in a loss of the sterile seal.
In August 2007, the white caps were replaced with clear caps of a different
material eliminating the potential for micro-cracks following sterilization. Only
seven (7) implants with micro-cracks, shipped prior to August 2007 to Canadian
dentists were retrieved and exchanged for newer product. When Ms. Fussi and
her sales managers at Nobel Biocare started to contact Implant Direct’s
customers with misinformation about Implant Direct’s packaging and Health
Canada’s response, Implant Direct initiated litigation that is now pending in
Canada."

Implant Direct satisfied the Canada Health authorities concerns by demonstrating that it had done dye leak tests on 125 implant vials with micro-cracks, which represented 25% of all such vials, and proved that these vials maintained the integrity of their sterile seal. CASE Closed!

Implant Direct initiated a voluntary inventory recovery in Canada, finding only 7 implant vials with Micro-cracks, and exchanged those products without incident. We have proposed to the FDA to do the same in the US but have not heard yet whether they think this is necessary. Recalls are not uncommon in the medical device industry as can be seen by the fact that Nobel is also listed as having a recall on the same Canada Health link provided on Cafepharma.

A search of the web under Nobel Biocare Recall reveals many incidences of Recalls by Nobel including 4 in a two month period as shown by this link.
http://mdiconsultants.com/section_ni/fda_recalls/recallarchive7.htm

While any incidence, voluntary or involuntary, requiring exchange or recall of products is unfortunate, Implant Direct's regulatory record is enviable, having only this one incident that did not in any way compromise sterility or clinical success. Nobel's attempt to exploit this by hiring a former employee of Implant Direct at $130,000 for the year, who was herself in charge of removing the products from Implant Direct's inventory at the request of our QA personnel, set in motion a series of events, the outcome of which has yet to be fully appreciated. Needless to say, if the FDA and Health Canada take seriously, Implant Direct's sale of a few implants with a cosmetic micro-crack that did not effect sterility, they are not likely to ignore the sale by Nobel Biocare, of hundreds of thousands of implants and other surgical components that potentially fail a simple dye leak test to assure the maintenance of sterility?

For you Nobel reps trying to console yourself by pointing at the Health Canada website listing a number of Implant Direct's implants that could potentially have been sold with micro-cracks (only 7 recovered and exchanged), here is something else to worry about. A study presented at the EAO meeting in Monico last week, comparing the results of Nobel Replace implants and Implant Direct RePlant implants placed side by side in maxillary jaws all using Nobel Guide and immediate loading, documented 13% of the Nobel Replace implants failed compared to only 1% of the RePlant Implants.

http://www.implantdirect.com/pdf/EAO_ImplGuidSurg_Final.pdf
 




Anonymous said:
Lets call a spade a spade here. Niznick, may know metallurgy and thread design, but he is an idiot when it comes to public relations and marketing. This is a classic example of stepping on one's own cock. Comical for sure. Idiotic, pathetic and ironic. Now the shit bag is no where to be seen. What will be most comical is how he will attempt to defend this serious breach of the law. Most likely he will blame Nobel for HIS packaging non compliance. He will say it is only the Canadian regulatory agency that has the issue, and that the US FDA is less strict, therefore not its not really an issue in the US. Let's see what this irrelevant desperate old man comes up with in response. Sometimes you need to let lying dogs lie. Niznick needs to understand this. Nobel has a much more educated, better financed team that this Niznick does. This whole thing is one of the funniest blunders I have seen in the business world. It shows sometimes people have more money than brains.
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Niznick not only knows metallurgy and thread design, he knows quality manufacturing and sterile packaging (he was the first to introduce sterile packaging in 1990 when Nobel was still telling people to wash their implants in alcohol and acetone). Nobel may know public relations and marketing better, but that won't help them if the FDA issues a massive recall of all the implant products Nobel sold as sterile in vials that failed the most basic dye leak tests. Nobel started this fight by hiring Implant Direct's former employee to turn over two year old implant vials to Health Canada that had been proven not to leak. The arrogance and stupidity of Mosher and Scala completely underestimated Niznick's capabilities for retaliation, namely by doing independent testing on Nobel's products, turning the results over to the FDA and then posting it on his website. If Nobel sells on credibility to justify its high prices and Niznick sells on value and innovation with low prices, who can get more hurt by a battle over credibility? As I see it, Nobel took a knife to a gunfight, and tried to take on a streetfighter like Niznick who has survived for over 25 years in this industry, fighting the establishment.
 








Unfortunately for Niznick this is only he beginning of a legal onslaught that will in the end further destroy his already marginal reputation for lack of science, credible claims, and sheer disdain by a large number of dentists. We hear about Niznick's concern for sterility and you also hear doctors speak about the time Niznick, dropped an implant on the floor during a live surgery, picking it up, washing it, and then placing it into a human being's jaw. Because he did not want to "waste" an implant. When someone is so obsessed with money, they will do anything to cut costs. There is no question that with low margins, and low sales volume as is the case with Implant Direct, there is little room for the company to completely insure there is safe packaging. Niznick minimizes the breach his company experienced, and endangered the lives of many patients in Canada, but claims it was not a huge issue. If it was not an issue why where you mandated to recall these implants? Why were you required to change the packaging? How many of these defective implants were actually placed into patients bones?
 




Dr. G Niznick said:
For you Nobel reps trying to console yourself by pointing at the Health Canada website listing a number of Implant Direct's implants that could potentially have been sold with micro-cracks (only 7 recovered and exchanged), here is something else to worry about. A study presented at the EAO meeting in Monico last week, comparing the results of Nobel Replace implants and Implant Direct RePlant implants placed side by side in maxillary jaws all using Nobel Guide and immediate loading, documented 13% of the Nobel Replace implants failed compared to only 1% of the RePlant Implants.

http://www.implantdirect.com/pdf/EAO_ImplGuidSurg_Final.pdf
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Any coincidence that this "comparison" is done by this crackpot from Spain is the same Dr lecturing at your wannabe symposium? You know the one where you have paid opinion leaders and spending all that $ to make claims for you? You know, the same type of symposium you lambasted other companies for doing? You know the same companies you also used to lambaste for having outside sales people while you were going to peddle your crap online with no need for "middleman?"

It would be funny if it werent so pathetic.
 




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