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The warning letter concerns observations made during an inspection thatwas initiated in September 2007. The letter primarily cites issues relatingto Stryker Biotech's handling of a past clinical study, its quality systemincluding medical device reporting procedures, and the integrity of hospitalInstitutional Review Board (IRB) documentation used to approve implantation ofHumanitarian Use Devices.
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Several corrective actions and changes to processes put in place byStryker Biotech were noted in the letter and future improvements areforthcoming as the division continues to work with FDA. No products have beenrecalled as a result of this warning letter. In addition, there were noobservations related to any ongoing clinical trials or clinical trial IRBs.
"We take this matter very seriously, will continue to cooperate fully withFDA, and have initiated significant measures to address FDA's concerns," saidStephen P. MacMillan, President and Chief Executive Officer of StrykerCorporation.
In addition to specific corrective actions implemented at the Biotechdivision, Stryker recently launched a company-wide Quality Action Plan aimedat strengthening corporate-level oversight and at institutionalizing a moreconsistent implementation of best practices for meeting FDA requirements.
"We are committed to strengthening our quality systems to fully meet allFDA requirements. While we have made progress in fulfilling this commitment,we still have more work to do" MacMillan added.
Forward-Looking Statements
This press release contains information that includes or is based onforward-looking statements within the meaning of the federal securities lawthat are subject to various risks and uncertainties that could cause theCompany's actual results to differ materially from those expressed or impliedin such statements. Such factors include, but are not limited to: pricingpressures generally, including cost-containment measures that could adverselyaffect the price of or demand for the Company's products; regulatory actions;unanticipated issues arising in connection with clinical studies and otherwisethat affect U.S. Food and Drug Administration approval of new products;changes in reimbursement levels from third-party payors; a significantincrease in product liability claims; changes in economic conditions thatadversely affect the level of demand for the Company's products; changes inforeign exchange markets; changes in financial markets; and changes in thecompetitive environment. Additional information concerning these and otherfactors is contained in the Company's filings with the U.S. Securities andExchange Commission, including the Company's Annual Report on Form 10-K andQuarterly Reports on Form 10-Q.
Stryker Corporation is one of the world's leading medical technologycompanies with the most broadly based range of products in orthopaedics and asignificant presence in other medical specialties. Stryker works withrespected medical professionals to help people lead more active and moresatisfying lives. The Company's products include implants used in jointreplacement, trauma, craniomaxillofacial and spinal surgeries; biologics;surgical, neurologic, ear, nose & throat and interventional pain equipment;and endoscopic, surgical navigation, communications and digital imagingsystems; as well as patient handling and emergency medical equipment. For moreinformation about Stryker, please visit the company web site atwww.stryker.com .As part of its Quality Action Plan Stryker has: -- Strengthened roles and responsibilities to increase accountability for quality
