According to Stryker Orthopedics, the voluntary recall was announced because of potential risks associated with the modular-neck stems (found at www.aboutstryker.com/modularneckstems). "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."
READ MORE STRYKER ORTHOPEDICS REJUVENATE LEGAL NEWS
According to a press release issued by Stryker (found online at www.fda.gov; 7/6/12), the recall affects global distribution of the Rejuvenate and ABG II modular-neck stems. "Following this action, we will work with the medical community to better understand this matter as we continue to evaluate this data," said Stuart Simpson, vice president and general manager, hip reconstruction.
On May 28, 2012, Health Canada announced that the Stryker Rejuvenate was being recalled to allow the instructions for use to be updated. That recall affected only devices sold in Canada and did not occur in the US.