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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