Navigation Links
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 healthcare professionals perform their jobs more efficiently while enhancing patient care.   The Company provides innovative orthopaedic implants as well as state-of-the-art medical and surgical equipment to help people lead more active and more satisfying lives.  For more information about Stryker, please visit

SOURCE Stryker Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Stryker Enters Strategic Marketing Agreement With Intuitive Surgical
2. Stryker Launches New Technologies and Celebrates a Major Clinical Milestone at The American Academy of Orthopaedic Surgeons Conference
3. Stryker to Host Conference Call on April 20, 2010
4. Stryker to Present at Investor Conference
5. Stryker Interventional Spine Launches VertaPlex(R) HV
6. Stryker to Host Analyst Meeting
7. Stryker Corporation Announces Pricing of Senior Notes
8. Stryker Updates Expected 2009 Results and Provides 2010 Outlook
9. Stryker Completes Acquisition of Ascent Healthcare Solutions
10. Stryker Announces $750 Million Share Repurchase Program and Declares a $0.15 Per Share Quarterly Dividend
11. RoundTable Healthcare Partners Announces Sale of Ascent Healthcare Solutions to Stryker Corporation
Post Your Comments:
(Date:12/1/2015)...  Today, AmerisourceBergen, a global healthcare ... first-of-its-kind population health management program focused on the ... be built into existing employer benefit packages, CareFront ... their care and explains how to avoid unnecessary ... help patients understand their treatment options and financially ...
(Date:12/1/2015)... DUBLIN , Dec. 01, 2015 ... addition of the "Medical Alert Systems/Personal Emergency ... and by Geography - Global Forecas" report ... has announced the addition of the "Medical ... Type, by End-User and by Geography - Global ...
(Date:12/1/2015)... ) has ... Technology Market 2015 - Forecast to 2020" ... ) has announced the addition of the ... 2020" report to their offering. --> ... announced the addition of the "Drug Delivery ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... , ... Growth in medical payments per workers’ compensation claim in Louisiana slowed ... nonhospital care, according to a recent study by the Workers Compensation Research Institute (WCRI). ... medical payments per claim with more than seven days of lost time continued to ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... medical images have been lifted as IMAGE Information Systems launches MED-TAB™ -- the ... North America Annual Meeting from November 29 to December 4, 2015. , ...
(Date:12/1/2015)... ... December 01, 2015 , ... Visage accelerates mobile imaging results ... subsidiary of Pro Medicus Ltd. (ASX: PME), has announced they are demonstrating new ... America (RSNA) 2015 annual meeting through December 3 in Chicago, Illinois, at Booth ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... ... clinical solutions for the care management and population health arenas, is pleased to ... clinical and cost containment services, has successfully implemented the ACUITY Complete Care™ Management ...
(Date:12/1/2015)... ... ... Nurotron Biotechnology Co., Ltd., maker of cochlear implant systems, has won a ... will be from the China Disabled Persons’ Federation, a central government association, for nearly ... children and adults suffering from severe and profound hearing loss . The company ...
Breaking Medicine News(10 mins):