Hologic, Inc. Issues Recall of BioZorb Marker Amid Issues Related to Implanted Devices

Hologic, Inc. Issues Recall of BioZorb Marker Amid Issues Related to Implanted Devices

It is important to note that the recall that began in March 2024 is intended as a correction rather than a complete withdrawal of the product.

The FDA categorizes the March 2024 recall as a Class I recall, which is the most severe level of recall due to the potential for these devices to lead to significant injury or even death.

The recall initiated in October 2024 involves the complete removal of all inventory of unused BioZorb Markers.

Details of the Recalled Product

  • Product Names: BioZorb Marker
  • Product Codes: NEU
  • 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
  • Distribution Dates: April 29, 2019 to April 1, 2024
  • Total Devices Recalled in the U.S.: 53,492
  • Date Recall Initiated: March 13, 2024

Usage of the Device

The BioZorb Marker, produced by Hologic (formerly Focal Therapeutics), is an implantable radiographic marker used primarily to mark soft tissue like breast tissue in preparation for various medical procedures, particularly those involving radiation. The device comprises two components: one permanent, made of titanium, and the other a temporary resorbable material that breaks down over time. Each marker is provided sterile and is intended for single use.

Reason for Recall

The recall of the BioZorb Marker by Hologic, Inc. stems from reports of complications and adverse incidents associated with the implanted devices. Issues reported include pain, infection, rash, migration, erosion, seroma, discomfort from the sensation of the device within the breast, and the necessity for further medical intervention to extract the device.

A total of 71 injuries have been reported, though there are no accounts of fatalities.

Potentially Affected Individuals

  • Patients who have received the BioZorb marker implant.
  • Those undergoing radiation guided by a potentially migrated BioZorb marker.
  • Individuals receiving systemic cancer treatments, which may be postponed due to complications from the BioZorb Marker.
  • Healthcare professionals such as radiologists, surgeons, oncologists, and others utilizing the BioZorb Marker in their treatment protocols.

Recommended Actions

On March 13, 2024, Hologic, Inc. issued an Important Medical Device Safety Notification to all impacted customers.

The notification advised patients to:

  • Reach out to their healthcare provider if they encounter any adverse reactions following the insertion of a BioZorb Marker.
  • Discuss the potential benefits and risks associated with implantable tissue markers for breast cancer treatments with their healthcare provider.
  • Notify Hologic at breasthealth.support@hologic.com and the FDA’s MedWatch Adverse Event Reporting program about any issues arising from the use of BioZorb Marker devices.

Healthcare providers were encouraged to:

  • Stay informed about serious adverse events related to the placement of BioZorb Marker devices.
  • Discuss potential benefits and risks with each patient utilizing the marker.
  • Inform patients regarding which device will be used if a Marker is necessary during breast conservation surgery.
  • Regularly monitor patients with a BioZorb Marker for adverse events.
  • Document any issues or complications reported by patients after the placement of the BioZorb Marker.

For Further Inquiries

Customers in the United States with questions related to this recall can reach out to Hologic, Inc. at breasthealth.support@hologic.com.

Additional Resources:

Reporting Issues

Healthcare professionals and the public can report any adverse reactions or quality concerns associated with these devices through MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or fax.