-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FNxPx+OzNdZ8DXIySO0utlvPHo85G/CwWctFaBqCxddWUQ7KmNUPj3aLcy7Cj8ad tVi76nmY7TN0tDTZlBWJPQ== 0000310764-10-000059.txt : 20100521 0000310764-10-000059.hdr.sgml : 20100521 20100521153545 ACCESSION NUMBER: 0000310764-10-000059 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100519 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100521 DATE AS OF CHANGE: 20100521 FILER: COMPANY DATA: COMPANY CONFORMED NAME: STRYKER CORP CENTRAL INDEX KEY: 0000310764 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 381239739 STATE OF INCORPORATION: MI FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-09165 FILM NUMBER: 10850971 BUSINESS ADDRESS: STREET 1: 2825 AIRVIEW BLVD CITY: KALAMAZOO STATE: MI ZIP: 49002 BUSINESS PHONE: 2693852600 MAIL ADDRESS: STREET 1: 2825 AIRVIEW BLVD CITY: KALAMAZOO STATE: MI ZIP: 49002 8-K 1 syk8k052110.htm www.stryker.com

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

                                             

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  May 19, 2010

                                               

 

STRYKER CORPORATION

(Exact name of registrant as specified in its charter)

 

Michigan

(State or other jurisdiction

of incorporation)

0-9165

(Commission

File Number)

38-1239739

(IRS Employer

Identification No.)

     

2825 Airview Boulevard, Kalamazoo, Michigan

(Address of principal executive offices)

49002

(Zip Code)

   

Registrant's telephone number, including area code:  269.385.2600

                                               

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

[ ]         Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

[ ]         Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

[ ]         Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

[ ]         Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 


 

ITEM 8.01

OTHER EVENTS

 

            The Company issued a press release on May 19, 2010 announcing that the U.S. Food and Drug Administration informed the Company that the actions undertaken to address issues raised in two Warning Letters received in 2007 and 2009 are sufficient.  A copy of this press release is attached hereto as Exhibit 99.1.

 

 

ITEM 9.01

FINANCIAL STATEMENTS AND EXHIBITS

 

(c)

Exhibits

 
     
  The following exhibit is included with this Report:
     
 

Exhibit 99.1

Press release dated May 19, 2010.

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

STRYKER CORPORATION

(Registrant)

 

May 21, 2010                                                             /s/ CURT R. HARTMAN

Date                                                                            Curt R. Hartman

Vice President and Chief Financial Officer

 


EX-99 2 ex99syk8k.htm www.stryker.com

EXHIBIT 99.1 

 

STRYKER ANNOUNCES RESOLUTION OF TWO FDA WARNING LETTERS

 

Kalamazoo, Michigan - May 19, 2010 - 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.

 

Contacts

For investor relations inquiries, please contact:

Katherine Owen, Vice President, Strategy and Investor Relations of Stryker Corporation, 269-385-2600
 
For media inquiries please contact:

Russell Weigandt, Kwittken & Company, rweigandt@kwitco.com and 646-747-7163 or stryker@kwitco.com

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