Stryker Initiates Voluntary Recall of Modular Neck Stems
On July 6, 2012, the FDA announced that Stryker voluntarily recalled the Rejuvenate and ABG II modular-neck stems.
Stuart Simpson, the Vice President and General Manager of Hip Reconstruction said, “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.”
According to the FDA, this decision comes after continued post-market surveillance. The data collected may be able to predict a trend. The company is going to work with the medical community in order to evaluate the date further. Stryker did announce that they notified healthcare professionals and regulatory bodies of this voluntary recall.
The risks associated with modular-neck stems, according to Stryker, include the potential for fretting and corrosion at or about the modular-neck junction. This can then lead to adverse tissue reactions that can create swelling or pain.
If you are a patient who has received a Rejuvenate Modular or ABG II modular-neck stem, please contact your surgeon. If you are not sure whether you have had one of these products implants, contact your surgeon or review your medical records in order to be sure. A call center is available to patients at 1-888-317-0200. Additional information can also be found at www.aboutstryker.com/modularneckstems.
If you or someone you love has had one of Stryker’s recalled modular neck-stems implanted and experienced pain, you may be entitled to compensation. Contact the experienced medical device lawyers of Childers, Schlueter & Smith, LLC for a free consultation.
This entry was posted
on Thursday, July 12th, 2012 at 7:43 pm and is filed under FDA Alerts Blog, News Blog.
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