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  5. Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices
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Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices

Update - October 25, 2024

Hologic Inc. announced a recall for removal of all lots of unused BioZorb Markers. See the related FDA Safety Communication for the most current information on these devices.

Please be aware, the recall initiated in March 2024 is a correction, not a product removal.

The FDA has identified the recall initiated in March 2024 as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The recall initiated in October 2024 is a removal of all lots of unused BioZorb Markers.

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
  • Devices Recalled in the U.S.: 53,492
  • Date Initiated by Firm: March 13, 2024

Device Use

The BioZorb Marker made by Hologic (previously Focal Therapeutics), is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures. Device has two components: a permanent component which is made of titanium metal and a resorbable component which is made of a plastic material that resorbes over time. It's provided sterile, meant for one-time use.

Reason for Recall

Hologic, Inc. is recalling Biozorb Marker due to complications and adverse events reported with implanted devices. 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.

There have been 71 reported injuries and no reports of death.

Who May be Affected

  • People who were implanted with the BioZorb marker device.
  • People who receive radiation guided by the BioZorb marker which may have migrated.
  • People who receive systemic cancer treatments as treatments may be delayed due to complications with BioZorb Marker.
  • Radiologist, surgeons, oncologists and other health care providers who use BioZorb Marker for treatment of their patients.

What to Do

On October 24, 2024, Hologic, Inc. recalled all lots of unused Biozorb Markers due to complications and adverse events reported with implanted devices. This update replaces the recommendations provided on March 13, 2024, by Hologic, Inc.  See the related FDA Safety Communication Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication for the most current information on these devices. 

Contact Information

Customers in the U.S. with questions about this recall should contact Hologic, Inc. at breasthealth.support@hologic.com.

Additional Resources:

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

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