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:6/23/2016)... 23, 2016 Roche (SIX: RO, ROG; OTCQX: ... its Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated ... shock. With this clearance, Roche is the first IVD ... solution for sepsis risk assessment and management. ... and PCT levels in blood can aid clinicians in ...
(Date:6/23/2016)... , June 23, 2016 , ... on Thursday, July 7, 2016 , , , , LOCATION: ... , , , , EXPERT PANELISTS:  , , , ... Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and ... The global pharmaceutical industry is witnessing an exceptional era. ...
(Date:6/23/2016)... June 23, 2016 The vast majority of ... dialysis facility.  Treatments are usually 3 times a week, ... visit, including travel time, equipment preparation and wait time. ... especially grueling for patients who are elderly and frail.  ... nursing and rehabilitation centers for some duration of time. ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and ... their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took ... the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... June ... about the dangers associated with chronic pain and the benefits of holistic treatments, ... individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of ... AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to ...
Breaking Medicine News(10 mins):