Stryker Issues Statement Regarding FDA Warning Letter

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

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:
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(SYK)