Stryker Announces Resolution of Two FDA Warning Letters

KALAMAZOO, Mich., May 19 /PRNewswire-FirstCall/ — Stryker
Corporation (NYSE: SYK) today announced that the U.S. Food and Drug
Administration (FDA) has informed the Company that the actions
undertaken to address issues raised in two Warning Letters received
in 2007 and 2009 are sufficient.  

The Company received a Warning Letter from FDA regarding
compliance with certain quality system requirements at its
reconstructive implant manufacturing facility in Cork, Ireland in 2007. In 2009, the
Company received a Warning Letter from FDA related to compliance
issues for one of its craniomaxillofacial (CMF) implant products
that was previously sold through its CMF distribution facility in
Portage, Michigan.  Following
FDA re-inspection of the Cork,
Ireland facility and additional corrective actions at both
the Cork and CMF facilities, the
Company has been notified  that issues raised have been
adequately addressed and no further formal corrective actions are
required.

“We are highly encouraged that the corrective actions undertaken
have been positively reviewed by FDA resulting in resolution of the
two remaining Warning Letters,” said Stephen P. MacMillan, Stryker’s Chairman,
President and Chief Executive Officer. “We are committed to ongoing
investments in our compliance systems and believe this latest news
supports the progress we are making in achieving our goals.”

About Stryker

Stryker is one of the world’s leading medical technology
companies and is dedicated to helping hea

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