2014

Smith & Nephew Issues Nationwide Recall of RF Denervation Probes Used for the Spine

    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: 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
     978-749-1330
 
 

SOURCE Smith & Nephew

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