Troublesome FDA could have major issues for once Biomet heads

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anonymous

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Latest FDA audits shut down Zim-Bio North campus, no product is leaving the building. Poor management that once ran Biomet is trying to cheat the ways of Zimmer operations. Save an American job, fire Robin Barney and bring ZimmerBiomet back into the lead again!
 


For sure!!! Zimmer operations knows all!! How many recalls has the great Zimmer operations team caused? Your the best! Keep up the good work! That way we all can be out of a job!
 




anonymous said:
Latest FDA audits shut down Zim-Bio North campus, no product is leaving the building. Poor management that once ran Biomet is trying to cheat the ways of Zimmer operations. Save an American job, fire Robin Barney and bring ZimmerBiomet back into the lead again!
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I've heard that the North Campus is still on ship hold. Hear that Surgical in Dover is also on hold. Can anyone confirm that this is still true? Great timing for Q4. WTF.
 






anonymous said:
Hold that thought. Check back after the FDA gets done with Biomet.
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Hold your thought...if it wasn't"t for Zimmer's outstanding relationship with the FDA..not to mention lack of quality control..what example would you like? What product recall that "your Zimmer operations" oversaw would YOU like to choose? Please explain to all of us how "Zimmer Operations" is the best? Never ONCE!! Has Biomet ever had an issue like this! Not until YOUR "Zimmer Operations" took over!!! Also... Name one major recall Biomet has ever had in their history! Oh...you can't can you!! Suck it!!
 


just a Biomet grunt rep exploited by my rich distributor. we have no juggernauts left. have to hand all of that business to Arthrex. gone forever. recon reps are freaking out.
 




anonymous said:
Hold your thought...if it wasn't"t for Zimmer's outstanding relationship with the FDA..not to mention lack of quality control..what example would you like? What product recall that "your Zimmer operations" oversaw would YOU like to choose? Please explain to all of us how "Zimmer Operations" is the best? Never ONCE!! Has Biomet ever had an issue like this! Not until YOUR "Zimmer Operations" took over!!! Also... Name one major recall Biomet has ever had in their history! Oh...you can't can you!! Suck it!!
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hahaha! Come on man, it was only a matter of time for Biomet. A private company with no real restrictions and no big brother watching. I mean lets think this through a little bit. These items on FDA hold are still being produced within the same Biomet machines under the same procedures that were in place when these products were released years ago. Soooo now it falls on Zimmer's lap and they are at fault??? More like those issues could have always been there, but now fall under the watchful eye due to being Zimmer Biomet. Either way, it's a major issue and the timing is even worse for us out in the field.
 


Barney was in operations before zimmer came in, all was fine then, check your facts, why would zimmer offer operations when they came in, if he wasn't,t doing a great job.
 
















That is the craziest 483 I've ever read. Some clown walked into the cleanroom wearing a "street clothes" while the FDA was auditing? What? Like a wife-beater and cut-offs? Come on son! Page 52 Observation 10. Paragraph B.

The warning letter is 58 pages long. 58! I bet that's longer than the entire design supporting documentation for half their products.

wtf where you people doing out there. no wonder the merger with zimmer was so critical. you knew as soon as fda showed up and looked up your skirt you wouldn't be able to sell anything.
 


anonymous said:
That is the craziest 483 I've ever read. Some clown walked into the cleanroom wearing a "street clothes" while the FDA was auditing? What? Like a wife-beater and cut-offs? Come on son! Page 52 Observation 10. Paragraph B.

The warning letter is 58 pages long. 58! I bet that's longer than the entire design supporting documentation for half their products.

wtf where you people doing out there. no wonder the merger with zimmer was so critical. you knew as soon as fda showed up and looked up your skirt you wouldn't be able to sell anything.
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Awesome!!!!!! Keep it up. Are the attorneys suing Zimmer paying attention! This is epic stuff!
 



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