Zimmer Biomet closes out FDA Warning Letter on Zhejiang, China manufacturing facility: 3 takeaways

Zimmer Biomet resolved the FDA’s June 3, 2015, Warning Letter.

Advertisement

Here are three takeaways:

 

1. The Warning Letter regarded Zimmer Biomet’s Zhejiang, China manufacturing facility.

 

2. During a January 2015 onsite inspection, the FDA found manufacturing practice issues.

 

3. Zimmer Biomet President and CEO noted the company “will continue to take the necessary actions to demonstrate our commitment to quality excellence, patient safety and regulatory compliance.”

 

More articles on devices:
Global spinal fusion devices market valued at $7.435M by 2022: 7 highlights
6 trends in the personalized orthopedic market
Amedica reports preliminary 2016 revenue of $15.2M — 10 highlights

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in Spinal Tech

  • From new product launches and leadership appointments, here are seven key headlines from Stryker in the first quarter of 2026.…

  • Xtant Medical’s 2025 revenue reached $133.9 million, a 14% increase year over year, according to financial results posted March 31.…

Advertisement

Comments are closed.