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

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....

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Compliance

Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

 

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.

Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Global Medtech Guidance Tracker: June 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

More from Policy & Regulation

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By 

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.