KALAMAZOO -- Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems.
Despite the products' name, they are used in hip implants.
Stryker said the recall was based on reports from the field of risks of corrosion and "fretting," corrosion made worse by abrasive wear. The company said the corrosion "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 center can be reached at (888) 317-0200 and additional information can be found at www.AboutStryker.com/ModularNeckStems.
Stryker stock closed down 67 cents or 1.2 percent Friday at $53.54.
for more features.