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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.


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Zimmer Holdings Inc.