The US Food and Drug Administration (FDA) has classified the recent Hologic BioZorb Marker recall as a Class I event, indicating a high risk of serious injury or death.

BioZorb Marker’s manufacturer Hologic has initiated the recall due to complications reported with the implanted devices, including pain, infection, and the need for additional medical treatment.

Designed to be used to mark soft tissue for future medical procedures, the BioZorb Marker has been distributed from 29 April 2019 to 1 April 2024.

The recall affects various model numbers, with 53,492 devices recalled in the US. The device, implanted into breast tissue, consists of a permanent titanium component and a resorbable plastic material.

Patients have reported 71 injuries, though no deaths have been associated with the device.

The reported complications include pain, infection, rash, device migration, device erosion, seroma, discomfort, and other issues related to feeling the device within the breast. These issues have sometimes necessitated additional medical interventions to remove the device.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The recall is a correction rather than a product removal, and Hologic has communicated with affected customers through an Important Medical Device Safety Notification sent on 13 March 2024.

The notification advised patients implanted with the BioZorb Marker to contact their healthcare provider if they experience any adverse events.

This recall may affect individuals who have been implanted with the BioZorb marker, those who receive radiation guided by the marker, and those undergoing systemic cancer treatments that could be delayed due to complications with the device.

Last month, Hologic agreed to acquire Endomagnetics (Endomag), a developer of breast cancer surgery technologies, for nearly $310m.