Hologic recalls more than 53,000 radiographic markers associated with 71 injuries

Hologic has recalled over 53,000 radiographic markers linked to 71 reported injuries, as per the FDA. While the devices remain available, Hologic urges reporting any adverse events, like pain, and advises physicians to discuss benefits and risks thoroughly.

This advisory comes two weeks after the FDA warned healthcare providers about potential complications with Biozorb markers. These devices mark soft tissue sites needing cancer radiation treatment, comprising a plastic component for gradual absorption and a permanent titanium part.

After reports in February revealed the plastic's persistence, potentially causing complications, the FDA communicated with physicians. In a Class I recall notice, the FDA outlined Biozorb device complaints, including pain, infection, rash, device migration, and other adverse events, though no fatalities were reported.

Hologic advises patients to promptly contact their healthcare provider if experiencing issues post-implantation. Physicians are advised to discuss risks, benefits, and monitor patients closely.