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
7210271 RF Denervation 602541, 602542, 602556, 602557,
Probe 602558, 602559, 602560, 602561,
602562, 602848,602849, 602999
7210272 RF Denervation 602543, 602570, 602571, 602850,
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: www.fda.gov/medwatch/report.htm
-- Regular Mail: use postage-paid FDA form 3500 available at:
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
SOURCE Smith & Nephew