KALAMAZOO, Mich., Jan. 22 /PRNewswire-FirstCall/ -- Stryker Corporation
(NYSE: SYK) today issued the following statement in response to recent media
attention regarding a Warning Letter dated November 28, 2007, that the United
States Food and Drug Administration (FDA) published on its web site on January
15, 2008.
While Stryker does not normally comment on discussions with the FDA, the
Company believes it is obligated to provide additional information to
healthcare professionals, providers and patients in light of several media
reports that draw erroneous conclusions surrounding the Warning Letter.
Most importantly, the Company does not believe there is any clinical
evidence to indicate that the products mentioned in the Warning Letter present
a safety issue to patients. Numerous published independent reports validate
the long-term clinical performance of these products.
The Company takes these matters very seriously and has been cooperating
fully with the FDA to address questions related to the FDA's observations of
Stryker's internal process specifications. As part of a comprehensive review
of internal processes following the FDA's observations, the Company conducted
an investigation into a deviation from its internal specifications and
processes for the Trident PSL and Hemispherical Acetabular Cups manufactured
in its Cork, Ireland facility.
The internal investigation confirmed that all Trident Acetabular products
manufactured in Cork, Ireland, have met all U.S. and international performance
standards for sterility and biocompatibility. However, results from that
testing indicated that the level of manufacturing residuals in some cases
exceeded the Company's internal acceptance criteria. It is important to note
this in no way impacts the product's sterility, nor product conformance to U.S.
and international biocompatibility standards. As a result of the deviation
from internal specifications, the Company is initiating a voluntary recall of
Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork
facility. Medical expert opinion of current and historical data concludes
that there are no safety issues for patients who received these products. In
fact, independent clinical evidence confirms that the performance of these
cups compares very favorably with other high performing acetabular
devices.(1,2,3)
Trident Acetabular Cups manufactured in the Company's Mahwah, New Jersey
facility are not part of the voluntary recall and are still available to
supply Stryker's customers.
The Company anticipates some short-term supply disruption as a result of
this action and is focused on eliminating these disruptions as expeditiously
as possible. In that regard, the manufacturing process for these cups in Cork
has now been validated, product shipments have resumed and the Company has
increased production at both the Mahwah and Cork facilities. Quality is a
Stryker core value and the Company remains committed to developing,
manufacturing and marketing medical products that are safe and effective and
that comply with applicable laws and regulations, including those administered
by the FDA and regulatory bodies in other countries in which Stryker conducts
business.
The Company does not anticipate any material financial impact on Stryker's
guidance for its 2008 results as a result of this voluntary recall. Details
regarding the Company's sales and earnings outlook will be provided in
conjunction with the release of its fourth quarter 2007 operating results on
Wednesday, January 23, 2008.
Forward-Looking Statements
This press release contains information that includes or is based on
forward-looking statements within the meaning of the federal securities law
that are subject to various risks and uncertainties that could cause the
Company's actual results to differ materially from those expressed or implied
in such statements. Such factors include, but are not limited to: pricing
pressures generally, including cost-containment measures that could adversely
affect the price of or demand for the Company's products; regulatory actions;
unanticipated issues arising in connection with clinical studies and eventual
FDA approval of new products; changes in reimbursement levels from third-party
payors; a significant increase in product liability claims; changes in
economic conditions that adversely affect the level of demand for the
Company's products; changes in foreign exchange markets; changes in financial
markets; and changes in the competitive environment. Additional information
concerning these and other factors are contained in the Company's filings with
the Securities and Exchange Commission, including the Company's Annual Report
on Form 10-K and Quarterly Reports on Form 10-Q.
Stryker Corporation is one of the world's leading medical technology
companies with the most broadly based range of products in orthopaedics and a
significant presence in other medical specialties. Stryker works with
respected medical professionals to help people lead more active and more
satisfying lives. The Company's products include implants used in joint
replacement, trauma, craniomaxillofacial and spinal surgeries; biologics;
surgical, neurologic, ear, nose & throat and interventional pain equipment;
and endoscopic, surgical navigation, communications and digital imaging
systems; as well as patient handling and emergency medical equipment. For more
information about Stryker, please visit the company web site at
www.stryker.com.
1. 2006 Annual Report of the Australian Orthopaedic Association. Retrieved
January 21, 2008, from http://www.aoa.org.au/docs/njrrrep06.pdf
2. Capello WN, D'Antonio JA, Manley MT, Feinberg JR. Arc-deposited
hydroxyapatite-coated cups: results at four to seven years. Clin
Orthop Relat Res. 2005 Dec; 441: 305-12.
3. D'Antonio JA, Manley MT, Capello WN, Bierbaum BE, Ramakrishnan R,
Naughton M, Sutton K. Five-year experience with Crossfire highly
cross-linked polyethylene. Clin Orthop Relat Res. 2005 Dec; 441: 143-
50.
SOURCE Stryker Corporation
CONTACT: Investors, Katherine A. Owen, Vice President, Strategy and
Investor Relations, +1-269-385-2600, Media, Aaron Kwittken, +1-646-747-7144,
stryker@kwitco.com, both of Stryker Corporation/
/Web site: http://www.stryker.com
http://www.aoa.org.au/docs/njrrrep06.pdf /
(SYK)