Hologic recalls BioZorb Marker due to complications with implanted devices

The FDA announced what it has identified as a Class I recall, “the most serious type of recall,” for the BioZorb Marker made by Hologic. “Hologic, Inc. is recalling Biozorb Marker due to complications and adverse events reported with implanted devices. Complaints included reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device. There have been 71 reported injuries and no reports of death,” the FDA notice stated.