Navigation Links
Stryker Announces Resolution of Two FDA Warning Letters
Date:5/19/2010

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 www.stryker.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... Research and Markets has announced the addition ... Industry Forecast to 2025" report to their offering. ... The Global Wireless Health ... over the next decade to reach approximately $330.5 billion by 2025. ... for all the given segments on global as well as regional ...
(Date:2/24/2017)... 2017 Research and Markets has announced the addition ... report to their offering. ... The latest research Dry eye Drugs Price Analysis and Strategies - ... market. The research answers the following questions: ... clinical attributes? How are they positioned in the Global Dry eye market? ...
(Date:2/24/2017)... Juan Monteverde , founder and managing ... boutique securities firm headquartered at the Empire State Building ... that a class action lawsuit has been filed in the ... Inotek Pharmaceuticals Corporation (NASDAQ:  ITEK)("Inotek" or the "Company") on ... 2015 and December 30, 2016, inclusive (the "Class Period").  ...
Breaking Medicine Technology:
(Date:2/26/2017)... San Mateo, CA (PRWEB) , ... February 26, 2017 , ... ... Bay Area cities as diverse as Millbrae, Belmont, and Palo Alto, is proud to ... San Mateo. Many Bay Area consumers look for home care close to home, and ...
(Date:2/26/2017)... ... February 26, 2017 , ... ... in staffing, scheduling, and reporting for healthcare organizations. This comprehensive and customizable ... entire staffing process. StaffBridge technology improves staffing efficiency, maximizes resource allocation, collects ...
(Date:2/26/2017)... Florida (PRWEB) , ... February 26, 2017 , ... ... of Parkinson’s disease (PD) in persons with a specific LRRK2 mutation, according to ... Congress. , Previous studies have provided evidence of a link between pesticides and ...
(Date:2/24/2017)... , ... February 24, 2017 , ... ... on tooth replacement options at his office, Antoine Dental Center. Currently, patients can ... $18,499. Some restrictions may apply, but patients can learn more about these offers ...
(Date:2/24/2017)... ... February 24, 2017 , ... An in-depth computational analysis of genetic variants ... points to eight genes that may explain why susceptibility to one of the disorders ... a study published today in the journal npj Schizophrenia. , “There is a ...
Breaking Medicine News(10 mins):