The FDA announced that one of the world’s leading medical technology companies, Styker, voluntarily recalled its Rejuvenate and ABG II modular-neck stems medical devices. The recall was brought forth after data showed the potential for fretting and corrosion at the modular-neck junction that can lead to adverse tissue reactions. The company had post-market surveillance set up that may predict a trend.
The announcement of this recall was on July 6, 2012. Stryker also notified regulatory bodies and healthcare professionals of the recall of these specific medical devices. According to Stryker, the number of complications with modular-neck stems is low. The patients who have been affected have experienced pain and/or swelling at the local joint site not attributable to other conditions. Some patients experienced aseptic loosening.
If you are a patient who has received a Rejuvenate Modular or ABG II modular-neck stem, please contact your surgeon. Patients can call 1-888-317-0200 for more information. 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.