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Stryker initiates voluntary recall of modular-neck stems
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Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems, according to an FDA release.
“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,” Stuart Simpson, vice president and general manager of hip reconstruction for Stryker, stated in the release.
The 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 company noted in the release, adding that 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,” Simpson stated in the release.
Stryker has notified healthcare professionals and regulatory bodies of the voluntary recall, according to the release.
Reference:
www.fda.gov
