Office of Medical Device and Radiological Health Division

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anonymous

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Dear Mr. Joseph Matrisciano Jr.

Program Division Director

Office of Medical Device and Radiological Health Division


My name is Benjamin Ghanoongooi, I am a Subject Matter Expert in medical sterilization and have been a quality manager for several contract sterilization facilities and have worked in my capacity as SME for number of medical devices manufacturing companies and have consulted for Internal and external audit in ISO 13485 and FDA CFR 820.

I was reviewing your referenced communication above to Medical Manufacturing company Zimmer Biomet. In this regard I have left both you and Ms. Archdeacon a message on your answering system.

I have several inquiries related to your communication and concerns thereof as stipulated in your communication dated August 24, 2018.

If you would please contact me with a convenient time for me to reach you, so I can address my inquires and additional findings that may relate to Zimmer Biomet manufacturing and sterilization practices.

I may be able to provide you relevant supporting evidence and documentation that may alleviate further negative public opinion on FDA , and how it handles investigations associated with this company. Hopefully, this will eliminate any further patient safety or physician liability utilizing products manufactured by Zimmer Biomet.




Thanking you in advance for looking into this matter.
 






I wonder how many orthopedic surgeons are on the hook for this . What would be the liability for the sales force who unknowingly marketed this product line. Lastly I wonder who would be the regulatory body/ agency that actually put the stamp of approval on such a product. Hopefully it is not TUV. They have not such a good reputation in the courts especially in EU.

Does anyone know how to get hold of this guy who wrote the letter to FDA?
 






That’s a sales pitch letter. Guy just wants some business. See dozens of letters like these from experts in every sector of industry. That is nothing more then a typical consultant sales pitch.
 












anonymous said:
That’s a sales pitch letter. Guy just wants some business. See dozens of letters like these from experts in every sector of industry. That is nothing more then a typical consultant sales pitch.
Click to expand...

Such a stupid comment , this response more likely is from a salesperson, who ignorantly trying to convince himself/herself that putting someone's life in danger is a normal way of making money. With that said we all take the responsibility and sign the code of conduct and at the end of the day we are all liable for misrepresenting the facts. Any one who has concern should contact and report this to their managers. This is the code any questions, any knowledge of negative remarks report to the management. So which is it looking the other way as business as usual or follow the law. This may be the same reason why company is going down the path of destruction less value of stocks , less trusted surgeons and negative public opinion.
Call it a sales pitch of trying to save lives ,lives of others who may never know who you are and what you are set in this life to do!
 






anonymous said:
Such a stupid comment , this response more likely is from a salesperson, who ignorantly trying to convince himself/herself that putting someone's life in danger is a normal way of making money. With that said we all take the responsibility and sign the code of conduct and at the end of the day we are all liable for misrepresenting the facts. Any one who has concern should contact and report this to their managers. This is the code any questions, any knowledge of negative remarks report to the management. So which is it looking the other way as business as usual or follow the law. This may be the same reason why company is going down the path of destruction less value of stocks , less trusted surgeons and negative public opinion.
Call it a sales pitch of trying to save lives ,lives of others who may never know who you are and what you are set in this life to do!
Click to expand...

You see the link? Obviously this is all this person has going for them in life.
 






























anonymous said:
The link below should clarify it for all those who still remain in confusion about the facts which do not know anything about.

Get the facts and think about your liability that comes with the paycheck you take home.

https://www.cbsnews.com/news/boston...evice-that-has-100000-women-suing-2019-04-17/
Click to expand...

apparently you don’t know the game, someone is always thrown under the bus, just don’t let that person be you. That’s why there’s so much middle management, always someone to take the fall. Just ask Depuy, you might be able to scare someone over there lol. Nobody here gives a flying fuck
 






anonymous said:
apparently you don’t know the game, someone is always thrown under the bus, just don’t let that person be you. That’s why there’s so much middle management, always someone to take the fall. Just ask Depuy, you might be able to scare someone over there lol. Nobody here gives a flying fuck
Click to expand...

Now we all know why we continue to pray for MDT to by Zimmer. You just made that point clear, as why companies like Zimmer continue to face litigation and false claims related court filings. The same goes for you too. With respect to the guy who put this post on at least he had the courage to put his name there on the document. Where are you with your peanuts in your shorts. We do not see your name on any document or correspondence do we? So next time you make a comment have respect for yourself to put your name to it.
Otherwise you certainly sound like a car salesman shifting from parking lots to medical offices.
 






anonymous said:
Now we all know why we continue to pray for MDT to by Zimmer. You just made that point clear, as why companies like Zimmer continue to face litigation and false claims related court filings. The same goes for you too. With respect to the guy who put this post on at least he had the courage to put his name there on the document. Where are you with your peanuts in your shorts. We do not see your name on any document or correspondence do we? So next time you make a comment have respect for yourself to put your name to it.
Otherwise you certainly sound like a car salesman shifting from parking lots to medical offices.
Click to expand...

this is an anonymous forum light bright. 99% of things here are false put by other companions because they know people like you take it all literally. Get real, wise up.
 






anonymous said:
Now we all know why we continue to pray for MDT to by Zimmer. You just made that point clear, as why companies like Zimmer continue to face litigation and false claims related court filings. The same goes for you too. With respect to the guy who put this post on at least he had the courage to put his name there on the document. Where are you with your peanuts in your shorts. We do not see your name on any document or correspondence do we? So next time you make a comment have respect for yourself to put your name to it.
Otherwise you certainly sound like a car salesman shifting from parking lots to medical offices.
Click to expand...

you sound like a pissed off 3rd grade teacher. WE NEED NAMES ON PAPERS. Lol. What an idiot coming to this forum.
 






Perhaps if you would have learned something in your third grade we would not be having this discussion.
Are you stating that a person's life is a game to you?
Then I suggest you go back to selling cars rather than medical products. That way when you go home take your paycheck you know the customer will be taking his car to the dealership for repair and part replacement.
 






To asshole above, Perhaps you’ll be in Pharma someday. As soon as a custodian position is posted you’ll have a shot at cleaning toilets again. Broke and stupid is no way to go through life Son!
 












anonymous said:
That’s a sales pitch letter. Guy just wants some business. See dozens of letters like these from experts in every sector of industry. That is nothing more then a typical consultant sales pitch.
Click to expand...

This is not a sales pitch , this is warning to those who claim to be in sales and marketing. Marketing defective unqualified product to the public. FDA as we all know it is in a very hot seat right now. This would add to it .
In any event you could simply contact the individuals in the correspondence and get more detail information
 






anonymous said:
This is not a sales pitch , this is warning to those who claim to be in sales and marketing. Marketing defective unqualified product to the public. FDA as we all know it is in a very hot seat right now. This would add to it .
In any event you could simply contact the individuals in the correspondence and get more detail information
Click to expand...
 






anonymous said:
This is not a sales pitch , this is warning to those who claim to be in sales and marketing. Marketing defective unqualified product to the public. FDA as we all know it is in a very hot seat right now. This would add to it .
In any event you could simply contact the individuals in the correspondence and get more detail information
Click to expand...

Nobody gives a shit but the salesman!!
 






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