16th Aug 2007 13:22
Smith & Nephew Plc16 August 2007 Smith & Nephew plc recall of 185 implants 16 August 2007 Smith & Nephew plc (LSE: SN, NYSE: SNN), the global medical technology business,announces that following a packaging error at a subcontractor it has voluntarilywithdrawn 185 of its BIRMINGHAM HIP* Resurfacing System implants which weremanufactured in a small number of production batches. Smith & Nephew have voluntarily withdrawn these implants and has notified the UKMedicines & Healthcare Products Regulatory Agency and the US Food & DrugAdministration that it has done so. These implants were incorrectly packaged by a subcontractor and as a result,different sizes of acetabular cup were mixed together. All hospitals andsurgeons who have received these implants have either been notified or are inthe process of being notified. Smith & Nephew's investigation confirms that this problem is confined to a smallnumber of batches. A number of implants have already been recovered in theirpackaging. The devices have been distributed to a number of countries,including the UK and the US. Smith & Nephew are working closely with patients and surgeons to ensure thatappropriate and immediate follow up takes place. Quality standards are anintegral part of the way Smith & Nephew does business and we continue tovigorously pursue and enforce these standards. Distribution of the BIRMINGHAM HIP Resurfacing product continues as normal andis meeting demand. Enquiries Investors/AnalystsLiz Hewitt Tel: +44 (0) 20 7401 7646Smith & NephewGroup Director Corporate Affairs MediaJon Coles Tel: +44 (0) 20 7404 5959Brunswick - London US MediaCindy Leggett-Flynn Tel: +1 (212) 333 3810Brunswick - New York About Smith & Nephew Smith & Nephew is a global medical technology business, specialising inOrthopaedic Reconstruction, Orthopaedic Trauma and Clinical Therapies, Endoscopyand Advanced Wound Management products. Smith & Nephew is a global leader inarthroscopy and advanced wound management and is one of the leading globalorthopaedics companies. Smith & Nephew is dedicated to helping improve people's lives. The Companyprides itself on the strength of its relationships with its surgeons andprofessional healthcare customers, with whom its name is synonymous with highstandards of performance, innovation and trust. The Company has 9,600 employeesand operates in 31 countries around the world generating annual salesapproaching $2.8 billion. Forward-Looking Statements This press release contains certain "forward-looking statements" within themeaning of the US Private Securities Litigation Reform Act of 1995. Inparticular, statements regarding expected revenue growth and trading marginsdiscussed under "Outlook" are forward-looking statements as are discussions ofour 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 identifyforward-looking statements. Such forward-looking statements involve known andunknown risks, uncertainties and other important factors (including, but notlimited to, the outcome of litigation, claims and regulatory approvals) thatcould cause the actual results, performance or achievements of Smith & Nephew,or industry results, to differ materially from any future results, performanceor achievements expressed or implied by such forward-looking statements. Pleaserefer to the documents that Smith & Nephew has filed with the U.S. Securitiesand Exchange Commission under the U.S. Securities Exchange Act of 1934, asamended, including Smith & Nephew's most recent annual report on Form 20F, for adiscussion of certain of these factors. All forward-looking statements in this press release are based on informationavailable to Smith & Nephew as of the date hereof. All written or oralforward-looking statements attributable to Smith & Nephew or any person actingon behalf of Smith & Nephew are expressly qualified in their entirety by theforegoing. Smith & Nephew does not undertake any obligation to update or reviseany forward-looking statement contained herein to reflect any change in Smith &Nephew's expectation with regard thereto or any change in events, conditions orcircumstances on which any such statement is based. * Trademark of Smith & Nephew. Certain marks registered US Patent and TrademarkOffice. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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