FDA states some patients have had to combat with follow up surgeries, and asked the complaints from patients be addressed....US manufacturing does not seem to be indicated, devices made in Cork, Ireland is the subject of the recall...BD
The company is recalling Trident PSL and Hemispherical Acetabular Cups that were made in its Cork, Ireland plant. Stryker, whose orthopedics division is based in Mahwah, N.J., said there are no safety issues for patients who received these products, based on expert opinion. Last week, the Food and Drug Administration ordered Kalamazoo-based Stryker to fix a host of long-standing problems in its manufacturing of hip replacement parts that have triggered multiple patient complaints and forced some to have follow-up surgeries.
Related story: http://www.medscape.com/viewarticle/569089?src=rss