Stryker Corporation : FDA Classifies Voluntary ShapeMatch® Cutting Guides
Recall as Class I Recall
Kalamazoo, Michigan - April 10, 2013 - Stryker Corporation (NYSE:SYK)
announced today that its orthopaedic division has received notice that the
U.S. Food and Drug Administration (FDA) has reviewed the voluntary recall of
its ShapeMatch Cutting Guides and that it will be classified as a Class I
ShapeMatch Cutting Guides are intended to be used as patient specific surgical
instrumentation to assist in the positioning of total knee replacement
components intraoperatively and in guiding the marking of bone before cutting.
In November 2012, Stryker Orthopaedics instructed all U.S. registered
ShapeMatch surgeons to discontinue use and ordering of ShapeMatch Cutting
Guides and in January 2013 voluntarily recalled the product. These actions
were due to the potential that ShapeMatch Cutting Guides may not have been
manufactured in accordance with surgeon preoperative planning parameters or
may have been manufactured outside of the planning ranges specified in the
510(k) clearance. This issue was identified through standard post-market
surveillance of product complaints. A Product Notification was issued to
surgeons and hospital risk managers which described the known hazards and
harms potentially associated with the use of the affected products, which
could result in a knee not functioning properly.
As stated in the January 2013 Product Notification, Stryker recommended that
patient follow-up beyond the routine standard of care was not necessary.
Patients who have had knee replacement surgery in which ShapeMatch Cutting
Guides were used and who feel their knee may not be functioning properly
should contact their surgeon. Patients may also contact Stryker at
1-888-STRYKER with questions regarding this Class I recall Monday - Friday,
The ShapeMatch Cutting Guides have not been available on the market since
November 2012. This voluntary recall does not affect the Triathlon Knee System
or the Triathlon standard instrumentation.
Stryker is one of the world's leading medical technology companies and is
dedicated to helping healthcare professionals perform their jobs more
efficiently while enhancing patient care. The Company offers a diverse array
of innovative medical technologies, including reconstructive, medical and
surgical, and neurotechnology and spine products to help people lead more
active and more satisfying lives. For more information about Stryker, please
For media inquiries please contact:
Yin Becker, Stryker Corporation, 201-831-5000 or email@example.com
For investor inquiries please contact:
Katherine A. Owen, Stryker Corporation, 269-385-2600 or
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Source: Stryker Corporation via Thomson Reuters ONE
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