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Zimmer: Surprised By Biomet Quality Problems, But Responded Before FDA Arrived

 
• By Elizabeth Orr

Zimmer Biomet's response to a US FDA Form-483 says the firm was unaware of the quality systems woes at the targeted Biomet Warsaw, Ind., plant before its 2015 acquisition of the company. But, it emphasized, comprehensive fixes were in the works even before the 2016 agency inspection that generated more than a dozen substantive observations took place.

Zimmer Biomet Holdings Inc. acknowledged major compliance weaknesses in pre-merger Biomet's quality control processes that Zimmer only learned about after its 2015 $13bn acquisition of the firm. But the orthopedic giant said it was well into fixing the issues before US FDA investigators came knocking in the fall of 2016.

Those details came out in a 282-page response letter from Zimmer Biomet to an unfavorable, late-2016 agency inspection....

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J&J’s Ethicon Issues Class I Correction For Echelon Stapler Reloads Amid Lockout Risk

 
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More from Policy & Regulation

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 
• By Brian Bossetta

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.

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