After a recent review of quality systems at the manufacturing facility, Zimmer determined that quality checks on certain orthopedic surgical products were lacking and that, as such, the products did not meet internal quality standards. As a result, the company initiated voluntary product recalls of certain OSP products and voluntarily and temporarily suspended production and sales of certain OSP products manufactured at the Dover facility. Zimmer says it will use the suspension to "focus the OSP organization on the needed improvements to manufacturing and conduct enhanced quality training for employees."
Zimmer has notified the FDA, distributors and end-users of the recalls. 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. The affected orthopedic surgical products do not include the company's core hip and knee implants business.
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 to $80 million, says the company. Additional detail on the expected impact will be provided during the company's first quarter investor conference call on April 24.