Stryker has voluntarily withdrawn its Rejuvenate and ABG II modular-neck stems from the market.
According to the company the recall was made due to potential risks associated with modular-neck stems. These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.
“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 centre can be reached at 1-888-317-0200 and additional information can be found here.