Zimmer has initiated a voluntary product recall at its Dover, Ohio Orthopedic Surgical Products facility after conducting a review of the quality systems of certain OSP products that the company has determined do not meet its internal quality standards.

Zimmer announced that the suspension will permit the company to focus its OSP organization on needed improvements to manufacturing, and to conduct enhanced quality training for employees, the release stated. Zimmer has notified the U.S. FDA, its distributors and end-users about the recalls. The company says that the recalls do not affect its core hip and knee implants business, the release noted.

The OSP division produces a variety of patient-care items used to support orthopedic surgery, including disposable products used in blood management, surgical wound-site debridement and cement accessories.
In 2007, Zimmer reported revenues from its OSP and other product category 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 million to $80 million, according to the release.

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