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:10/12/2017)... -- AVACEN Medical , Inc. (AVACEN) announced that Frost ... Product Innovation Award for Its fibromyalgia pain management device. ... device market research by Frost & Sullivan,s industry experts. ... relief product, the AVACEN 100, offers a safe and effective ... ...
(Date:10/12/2017)... Pa. , Oct. 12, 2017 ... leader in innovative solutions for injectable drug administration, today ... before the market opens on Thursday, October 26, 2017, ... the results and business expectations at 9:00 a.m. Eastern ... (U.S.) or 253-336-8738 (International). The conference ID is 94093362. ...
(Date:10/11/2017)... Oct. 11, 2017  Caris Life Sciences ® , ... the promise of precision medicine, today announced that St. ... Precision Oncology Alliance™ (POA) as its 17 th ... St. Jude Crosson Cancer Institute will help develop standards ... of tumor profiling, making cancer treatment more precise and ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, ... ... School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, ... professionals on guideline updates for the primary prevention of cardiovascular diseases during ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes ... a mock evacuation of the facility as part of a disaster drill on October ... Hose EMS and Shelton City Emergency Manager, as well as the Connecticut Long ...
(Date:10/13/2017)... , ... October 13, 2017 , ... The Visiting Nurse ... Market. Featuring a collection of specialty vendors and unique items from across the nation, ... quality-focused health and wellness services offered by the VNA. The boutique will be ...
(Date:10/13/2017)... NJ (PRWEB) , ... October 13, 2017 , ... Global ... at scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global ... physical activity. The fun run is geared towards children of all ages; it ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob ... sciatica in a new episode of "Success Files," which is an award-winning educational ... and investigates each subject in-depth with passion and integrity. , Sciatica occurs when ...
Breaking Medicine News(10 mins):