Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News

Zimmer Holdings Inc.

FDA Compliance

Zimmer Recalls Patient Care Product Lines

Published: Tuesday, April 22, 2008 - 22:00

(Zimmer Holdings Inc.: Warsaw, Indiana) -- Zimmer Holdings Inc. has recently taken a number of actions to improve quality systems at its Dover, Ohio, facility, which manufactures Zimmer Orthopedic Surgical Products (OSP).

Zimmer recently conducted a review of quality systems at the Dover, Ohio OSP facility and initiated voluntary product recalls of certain OSP products manufactured at the Dover facility that did not meet internal quality standards. In addition, Zimmer voluntarily suspended production and sales of certain OSP products manufactured at the Dover facility. The suspension will permit Zimmer to focus the OSP organization on the needed improvements to manufacturing and conduct enhanced quality training for employees.

The OSP division produces a variety of patient care items used to support orthopedic surgery, including disposables used in blood management, surgical wound site debridement and cement accessories. In 2007, Zimmer reported revenues from its OSP and other product categories of $234 million, less than half of which were generated by products affected by the recalls and suspension. These actions are expected to adversely impact 2008 OSP revenues by $70 to $80 million. Additional detail on the expected impact will be provided during Zimmer’s first quarter investor conference call on April 24, 2008.

Zimmer has notified the U.S. Food and Drug Administration, distributors and end-users of the recalls. These recalls do not affect the company’s core hip and knee implants business.

For more information, visit www.zimmer.com/z/ctl/op/global/action/1/id/10071/template/CP.

Discuss

About The Author

Zimmer Holdings Inc.’s default image

Zimmer Holdings Inc.