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Smith & Nephew plc recall of 185 implants


Smith & Nephew plc (LSE: SN, NYSE: SNN), the global medical technology business, announces that following a packaging error at a subcontractor it has voluntarily withdrawn 185 of its BIRMINGHAM HIP◊ Resurfacing System implants which were manufactured in a small number of production batches.

Smith & Nephew have voluntarily withdrawn these implants and has notified the UK Medicines & Healthcare Products Regulatory Agency and the US Food & Drug Administration that it has done so.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 and surgeons who have received these implants have either been notified or are in the process of being notified.

Smith & Nephew’s investigation confirms that this problem is confined to a small number of batches.  A number of implants have already been recovered in their packaging.  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 that appropriate and immediate follow up takes place.  Quality standards are an integral part of the way Smith & Nephew does business and we continue to vigorously pursue and enforce these standards.

Distribution of the BIRMINGHAM HIP◊ Resurfacing product continues as normal and is meeting demand.


About us

Smith & Nephew is a global medical technology business, specializing in Orthopaedic Reconstruction, Orthopaedic Trauma & 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 of nearly $2.8 billion.


Forward-Looking Statements

This press release contains certain "forward-looking statements" within the meaning of the US Private Securities Litigation Reform Act of 1995.  In particular, statements regarding planned growth in our business and in our trading 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.


Enquiries

Investors/Analysts
Liz Hewitt                      
Smith & Nephew
Group Director Corporate Affairs
Tel: +44 (0) 20 7401 7646

Media
Jon Coles 
Brunswick – London
Tel: +44 (0) 20 7404 5959

Cindy Leggett-Flynn 
Brunswick – New York
Tel: +1 (212) 333 3810

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