Recall -- Firm Press Release
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Stryker Initiates Voluntary Product Recall of Modular-Neck Stems
Action Specific to Rejuvenate and ABG II Modular-Neck Stems
FOR IMMEDIATE RELEASE - July 6, 2012 - Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems.
"While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action," said Stuart Simpson, Vice President and General Manager, Hip Reconstruction.
Stryker Orthopaedics’ decision to voluntarily remove Rejuvenate and ABG II modular-neck stems and terminate global distribution of these products comes after continued post-market surveillance. The post-market surveillance data may be predictive of a trend. "Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data," said Simpson.
Stryker has notified healthcare professionals and regulatory bodies of this voluntary recall. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to contact their surgeon. Patients uncertain if they have one of these products implanted should contact their surgeon or consult their medical records.
A dedicated patient call center can be reached at 1-888-317-0200 and additional information can be found at www.AboutStryker.com/ModularNeckStems .
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 visit www.stryker.com .