FDA Flags High-Risk Recall: Hologic’s BioZorb Markers Under Scrutiny

The US Food and Drug Administration has labeled Hologic’s ongoing recall of its BioZorb Markers as Class I high-risk, highlighting what some patient safety advocates say are ongoing concerns about devices cleared via the 510(k) pathway.

BioZorb Markers are radiographic markers implanted in soft tissue, such as breasts, to mark them for future future surgical interventions or radiation therapy planning. They include a permanent titanium component as well as a plastic component that resorbs over time. Hologic first initiated a recall of the products in