• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Stryker Initiates Voluntary Product Recall of Modular-Neck Stems
Action Specific to Rejuvenate and ABG II Modular-Neck Stems

 

Contact
Consumer:
888-317-0200
www.AboutStryker.com/ModularNeckStems disclaimer icon

Media:
Jeanine Guilfoyle
Stryker Orthopaedics
201-831-6277
jeanine.guilfoyle@stryker.com

Investor Contact:
Katherine Owen
Stryker Corporation
269-385-2600
katherine.owen@stryker.com

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 disclaimer icon .

About Stryker
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 disclaimer icon .

 

###

RSS Feed for FDA Recalls Information [what's this?]