-----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, RFy3agXm88x9a4WRInFVGff3U3jTI7GL9kXC5lXM+6jOa/RwgyAC5+G+ae+ZFqvX acPGcQmlKS7Q3RwDPsrmDA== 0000914317-09-001834.txt : 20090909 0000914317-09-001834.hdr.sgml : 20090909 20090909151233 ACCESSION NUMBER: 0000914317-09-001834 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090909 ITEM INFORMATION: Other Events FILED AS OF DATE: 20090909 DATE AS OF CHANGE: 20090909 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CONMED CORP CENTRAL INDEX KEY: 0000816956 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 160977505 STATE OF INCORPORATION: NY FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-16093 FILM NUMBER: 091060541 BUSINESS ADDRESS: STREET 1: 525 FRENCH ROAD CITY: UTICA STATE: NY ZIP: 13502 BUSINESS PHONE: 315-624-3215 MAIL ADDRESS: STREET 1: 310 BROAD STREET STREET 2: 525 FRENCH ROAD CITY: UTICA STATE: NY ZIP: 13502 8-K 1 form8k-102676_cnmd.htm FORM 8K form8k-102676_cnmd.htm

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):  September 9, 2009


CONMED CORPORATION
    (Exact name of registrant as specified in its charter)


New York
 
0-16093
 
16-0977505
(State or other jurisdiction of
 
(Commission
 
(I.R.S. Employer
incorporation or organization)
 
File Number)
 
Identification No.)



525 French Road
Utica, New York 13502
(Address of principal executive offices, including zip code)



(315) 797-8375
(Registrant's telephone number, including area code)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions (See General Instruction A.2 below):

¨           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))



 
 

 




Section 8                      Other Events
Item 8.01                      Other Events

On September 9, 2009, CONMED Corporation announced a voluntary recall for certain serial numbers of the PRO5 & PRO6 series battery handpieces, and certain lots of the MC5057 Universal Cable.

The information in this Current Report on Form 8-K that is furnished under “Item 8.01 Other Events” and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Act of 1934, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

The following exhibit is included herewith:

 
Exhibit No.
Description of Exhibit
     
 
99.1
Press Release dated September 9, 2009, issued by CONMED Corporation.


 
 

 

Signature

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 thereunto duly authorized.



 
CONMED CORPORATION
 
               (Registrant)
     
     
 
By:
  Robert D. Shallish, Jr.
   
Vice President-Finance and
   
     Chief Financial Officer


Date:           September 9, 2009





 
 
 
 
 

 
 
 

 

 

EXHIBIT INDEX

Exhibit
   
Number
 
Exhibit Description
     
99.1
 
Press Release, dated September 9, 2009, issued by CONMED Corporation.









































 
EX-99.1 CHARTER 2 ex99-1.htm EXHIBIT 99.1 ex99-1.htm

LOGO                       NEWS RELEASE


 
CONTACT:
 
CONMED Corporation
 
Robert Shallish
 
Chief Financial Officer
 
315-624-3206
   
 
FD
 
Investors:  Evan Smith/Brian Ritchie
 
212-850-5600


FOR RELEASE:   7:00 AM (Eastern)   September 9, 2009

CONMED Corporation Announces Voluntary Recall of Certain Powered Surgical Instrument Products
- PRODUCTS INCLUDED IN THE RECALL:
·  
PRO5 and PRO6 Series Handpieces Manufactured and Distributed Prior to May 31, 2008
·  
MC5057 Universal Cable Manufactured and Distributed Prior to December 1, 2006

Utica, NY – September 9, 2009 – CONMED Corporation’s (Nasdaq:  CNMD) CONMED Linvatec unit announced today a voluntary recall for certain model numbers of the PRO5 & PRO6 series battery handpieces manufactured prior to May 31, 2008, and certain lots of the MC5057 Universal Cable manufactured prior to December 1, 2006 used with certain of CONMED Linvatec’s electric powered handpieces.    CONMED Linvatec issued Medical Device Safety Alert letters to customers dated July 31, 2009 providing information on findings from the Company’s ongoing continuous quality improvement process.  Following discussions with the Food and Drug Administration, CONMED Linvatec has now developed a voluntary recall program for the affected products.  The recall program is more fully described below.

In the PRO5 and PRO6 Medical Device Safety Alert Letter, CONMED Linvatec notified customers about the unlikely possibility for units to potentially self-activate. The letter also reminded customers that safe and effective use of the handpieces includes inserting the battery away from the operation site along with not touching or coming into contact with moving parts while inserting the battery, and to follow recommended handling and user instructions.  An additional letter listing the affected serial numbers of units is in process of being sent to customers who have the PRO5 & PRO6 series battery handpieces. They will be requested to contact ConMed Linvatec to schedule the return and service of their units.  Units manufactured and distributed AFTER May 31, 2008 are not affected by this action.

In the MC5057 Medical Device Safety Alert Letter, CONMED Linvatec notified customers about the unlikely possibility for cables manufactured prior to December 1, 2006, to cause an electric powered handpiece to potentially self-activate. The letter instructed customers to avoid moving parts on the handpiece when the cable is inserted and to follow recommended
 
 
 
 

 
 
Page 2 of  3
 
handling and user instructions.  CONMED Linvatec is in the process of notifying customers that have the affected MC5057 Universal Cable.  These customers will be instructed to contact CONMED Linvatec to schedule the return of their cables for replacements.  MC5057 Universal Cables manufactured and distributed AFTER December 1, 2006 are not affected by this action.

Self-activation may in some circumstances cause injury, although CONMED Linvatec has received no reports of any injuries with respect to the PRO5 or PRO6 handpieces.  With respect to the cables, CONMED Linvatec has received no reports of injuries to patients.  There were, however, two reports of non-serious injuries to medical personnel, with both reports occurring in 2006 in situations in which the users did not follow the instructions for use. In the unlikely event that a battery handpiece behaves erratically, users should cease using it and contact customer service at CONMED Linvatec.  Likewise, users should not deploy cables with excessive wear or damage.


CONMED Linvatec customers are being reminded that routine preventive maintenance may help to ensure optimum operating performance over the life of the handpiece. Customers are encouraged to contact CONMED Linvatec with any questions or concerns at 1-800-535-8536 or email at CustServ1@linvatec.com.  Customers are also reminded that any adverse experiences with the use of these products, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch


CONMED currently estimates the pre-tax cost of completing the recall will approximate $6.0 million, which will be expensed in the Company’s financial statements for the quarter ending September 30, 2009.


CONMED Profile

CONMED is a medical technology company with an emphasis on surgical devices and equipment for minimally invasive procedures and patient monitoring.  The Company’s products serve the clinical areas of arthroscopy, powered surgical instruments, electrosurgery, cardiac monitoring disposables, endosurgery and endoscopic technologies.  They are used by surgeons and physicians in a variety of specialties including orthopedics, general surgery, gynecology, neurosurgery and gastroenterology.  Headquartered in Utica, New York, the Company’s 3,200 employees distribute its products worldwide from several manufacturing locations.

 
Forward Looking Information
 

 
This press release contains forward-looking statements based on certain assumptions and contingencies that involve risks and uncertainties.  The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and relate to the Company’s performance on a going-forward basis.  The forward-looking statements in this press release involve risks and uncertainties which could cause actual results, performance or trends, to differ materially from those expressed in the forward-looking statements herein or in previous disclosures.  The Company believes that all forward-looking statements made by it have a reasonable basis, but there can be
 
 
 
 

 
 
Page 3 of 3
 
no assurance that management’s expectations, beliefs or projections as expressed in the forward-looking statements will actually occur or prove to be correct.  In addition to general industry and economic conditions, factors that could cause actual results to differ materially from those discussed in the forward-looking statements in this press release include, but are not limited to: (i) the failure of any one or more of the assumptions stated above, to prove to be correct; (ii) the risks relating to forward-looking statements discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008; (iii) cyclical purchasing patterns from customers, end-users and dealers;  (iv) timely release of new products, and acceptance of such new products by the market; (v) the introduction of new products by competitors and other competitive responses; (vi) the possibility that any new acquisition or other transaction may require the Company to reconsider its financial assumptions and goals/targets; and/or (vii) the Company’s ability to devise and execute strategies to respond to market conditions.

#   #   #



 
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