Recall of 185 implants
Smith & Nephew Plc
16 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 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withdrawn 185 of its BIRMINGHAM HIP* Resurfacing System implants which were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Smith & Nephew have voluntarily withdrawn these implants and has notified the UK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.
Enquiries
Investors/Analysts
Liz Hewitt Tel: +44 (0) 20 7401 7646
Smith & Nephew
Group Director Corporate Affairs
Media
Jon Coles Tel: +44 (0) 20 7404 5959
Brunswick - London
US Media
Cindy Leggett-Flynn Tel: +1 (212) 333 3810
Brunswick - New York
About Smith & Nephew
Smith & Nephew is a global medical technology business, specialising 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 9,600 employees
and operates in 31 countries around the world generating annual sales
approaching $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 expected revenue growth and 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, claims 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.
* Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark
Office.
This information is provided by RNS
The company news service from the London Stock Exchange
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