On July 6, 2012 Stryker Orthopaedics announced the decision to recall its Rejuvenate Modular and ABG II modular hip stem replacements. The reasons for voluntary recalls, such as the one issued by Stryker, can vary significantly. Thus, it is important for patients to understand why the recall was issued and what they should do if they have a Rejuvenate Modular or ABG II hip stem in their body.
What are the possible reasons for the Stryker recall decision?
Post-market surveillance data, or information about patients who have already had the Rejuvenate Modular or ABG II modular hip stem replacements used in their surgeries, indicated a potential problem with these medical devices. Reports indicate that the FDA may have received 45 or more adverse event reports about these two medical devices during the first half of 2012.
Perhaos Stryker is concerned that the reported reactions in the local tissue near the site of the Rejuvenate Modulars or ABG IIs may be indicative of a trend. Specifically, are they concerned about the possibilities of fretting and erosion? According to its release, the company decided to stop "global distribution" of these products. However, the company has said that it will continue to evaluate the data coming in on these hip stem replacement products and to work with the medical community. So the company claims it is not a "recall" but simply that they are stopping sales.
What to Do if You Have a Recalled Medical Device in Your Body
If you have had hip replacement surgery then there are several things that you can do. First, check with your surgeon to determine exactly what medical devices were used during your surgery. Then, check with your surgeon and the FDA to determine if there have been any recalls of the medical devices used. If a recall has been issued, it is important to know why and to watch for any symptoms of a problem. Regular checkups may be necessary. Additionally, if you suffer harm from a Stryker Rejuvenate Modular or ABG II hip stem replacement, or any other recalled hip implant device, then it is important to contact an experienced hip implant recall lawyer for more information about your protecting your legal rights and about your potential legal recovery.