Smith & Nephew Issues Nationwide Recall of RF Denervation Probes Used for the Spine
27 March 2007 - 9:00AM
PR Newswire (US)
ANDOVER, Mass., March 26 /PRNewswire-FirstCall/ -- Smith &
Nephew Inc. is initiating a nationwide recall of 539 RF Denervation
probes for the part numbers and models listed in the table below.
The Smith & Nephew RF Denervation probes are indicated for use
exclusively with the Smith & Nephew ELECTROTHERMAL(TM) 20S
SPINE SYSTEM in RF heat lesion procedures for the relief of pain.
The RF Denervation Probes, which are provided in a non-sterile
condition, were mislabeled as sterile which potentially could
result in a patient infection. Customers who have product that is
being recalled should return it to Smith & Nephew per the
recall instructions. The recall includes the following products and
lot numbers: Part # Description Lot numbers 7210270 RF Denervation
602549, 602550, 602846, 602847 Probe 7210271 RF Denervation 602541,
602542, 602556, 602557, Probe 602558, 602559, 602560, 602561,
602562, 602848,602849, 602999 7210272 RF Denervation 602543,
602570, 602571, 602850, Probe 603000 The company voluntarily
recalled the products after learning of the labeling error. FDA has
been apprised of this action. No injuries have been reported to
date associated with this issue. Product was distributed to 134
domestic and international customers. It can be identified by the
product number, name, and lot numbers identified above. Smith &
Nephew has notified its distributors and customers and is arranging
for return and replacement of all recalled products. Consumers with
questions may contact the company at 1-800-343-5717. Adverse
reactions or quality problems experienced with the use of this
product may be reported to the FDA's MedWatch Adverse Event
Reporting program either online, by regular mail or by fax. --
Online: http://www.fda.gov/medwatch/report.htm -- Regular Mail: use
postage-paid FDA form 3500 available at:
http://www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600
Fishers Lane, Rockville, MD 20852-9787 -- Fax: 1-800-FDA-0178 About
Smith & Nephew Smith & Nephew is a global medical
technology business, specializing in Orthopaedic Reconstruction,
Orthopaedic Trauma and Clinical Therapies, Endoscopy and Advanced
Wound Management products. Smith & Nephew is a global leader in
arthroscopy and advanced wound management and is one of the leading
global orthopaedics companies. Smith & Nephew is dedicated to
helping improve people's lives. The Company prides itself on the
strength of its relationships with its surgeons and professional
healthcare customers, with whom its name is synonymous with high
standards of performance, innovation and trust. The Company has
8,800 employees and operates in 31 countries around the world
generating annual sales approaching $2.8 billion. This press
release contains certain "forward-looking statements" within the
meaning of the U.S. Private Securities Litigation Reform Act of
1995. In particular, statements regarding planned growth in our
business and in our operating margins discussed under "Outlook" are
forward-looking statements as are discussions of our product
pipeline. These statements, as well as the phrases "aim", "plan",
"intend", "anticipate", "well-placed", "believe", "estimate",
"expect", "target", "consider" and similar expressions, are
generally intended to identify forward-looking statements. Such
forward- looking statements involve known and unknown risks,
uncertainties and other important factors (including, but not
limited to, the outcome of litigation and regulatory approvals)
that could cause the actual results, performance or achievements of
Smith & Nephew, or industry results, to differ materially from
any future results, performance or achievements expressed or
implied by such forward-looking statements. Please refer to the
documents that Smith & Nephew has filed with the U.S.
Securities and Exchange Commission under the U.S. Securities
Exchange Act of 1934, as amended, including Smith & Nephew's
most recent annual report on Form 20F, for a discussion of certain
of these factors. All forward-looking statements in this press
release are based on information available to Smith & Nephew as
of the date hereof. All written or oral forward-looking statements
attributable to Smith & Nephew or any person acting on behalf
of Smith & Nephew are expressly qualified in their entirety by
the foregoing. Smith & Nephew does not undertake any obligation
to update or revise any forward-looking statement contained herein
to reflect any change in Smith & Nephew's expectation with
regard thereto or any change in events, conditions or circumstances
on which any such statement is based. Contact: Joe Metzger Smith
& Nephew Endoscopy 978-749-1330 DATASOURCE: Smith & Nephew
CONTACT: Joe Metzger of Smith & Nephew Endoscopy,
+1-978-749-1330 Web site: http://www.smith-nephew.com/
http://www.fda.gov/medwatch/report.htm
http://www.fda.gov/MedWatch/getforms.htm
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