Zimmer recalls, temporarily suspends production of certain product lines at Ohio facility
WARSAW, Ind. After conducting a recent review of the quality systems at its Dover, Ohio, Orthopaedic Surgical Products facility, Zimmer has initiated voluntary product recalls of certain OSP products manufactured at the facility that the company has determined do not meet its internal quality standards, Zimmer announced in a press release.
Additionally, the company has voluntarily and temporarily suspended both production and sales of certain Orthopaedic Surgical Products (OSP) manufactured at the Dover facility. The suspension will permit Zimmer to focus its OSP organization on needed improvements to manufacturing, and to conduct enhanced quality training for employees, the release stated.
The recalls do not affect the Zimmer's core hip and knee implants business, the release noted.
Zimmer has notified the U.S. FDA, its distributors and end-users about the recalls.
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.