Dozens of injuries trigger FDA recall of over 50,000 implantable tissue marking devices
The U.S. Food and Drug Administration has announced a Class I recall of over 50,000 soft tissue marker devices made by Hologic, Inc.
The recall affects the BioZorb Marker and BioZorb LP Marker—devices that are implanted into soft tissue, often in the breast, to mark a region so that it can be easily identified during future medical procedures, like radiation therapy.
The device includes two components—one that is made of titanium metal and is permanent, and one that is plastic and resorbs over time.
The recall includes the following model numbers:
F0405 BioZorb Marker 4cm x 5cm
F0404 BioZorb Marker 4cm x 4cm
F0331 BioZorb Marker 1cm x 3cm x 3cm
F0231 BioZorb Marker 1cm x 3cm x 2cm
F0221 BioZorb Marker 1cm x 3cm x 2cm
F0304 BioZorb Marker 3cm x 4cm
F0303 BioZorb Marker 3cm x 3cm
F0203 BioZorb Marker 2cm x 3cm
F0202 BioZorb Marker 2cm x 2cm
The Class I recall, which is the most serious recall the FDA issues, comes after numerous reports of adverse events and complications linked to the radiographic markers.
“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,” the FDA’s notice says.
So far, 71 injuries related to the marker have been reported.
Hologic sent a safety notification to affected customers in March. In that notice, Hologic advised patients who had already had the device implanted to monitor themselves for symptoms of an adverse reaction and report any complications to breasthealth.support@hologic.com and to the FDA’s MedWatch Adverse Event Reporting program.
The recall is a correction, not a product removal.
Read the full recall notice here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.