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  5. Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due to Risk for Patient Complications
  1. Medical Device Recalls

Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due to Risk for Patient Complications

This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

  • Product Names: BioZorb Marker and BioZorb LP Marker
  • Product Codes: NEU
  • Product Part 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
  • Product Description and UDI:
  • Lot numbers: All unused lot numbers

What to Do

  • Do not use BioZorb Marker and BioZorb LP Marker.
  • Monitor patients who have an implanted BioZorb Marker for signs of any adverse events.

On October 24, 2024, Hologic sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:

For Patients

  • Be aware that there is no need to have the BioZorb Marker removed from your body (explanted), unless your health care provider says otherwise.
  • Contact your health care provider if you experience any adverse events after you receive a BioZorb Marker.
  • Report any problems or complications with your BioZorb Marker to the FDA.
  • Discuss possible risks with a health care provider if you have a BioZorb Marker and/or the provider plans radiation therapy treatment.

For Health Care Providers

  • Do not implant BioZorb Markers
  • Be aware of reports of serious adverse events after placement of BioZorb Marker devices in breast tissue.
  • Monitor patients who have an implanted BioZorb Marker for signs of any adverse events.
  • Be aware the FDA has not cleared or approved the use of BioZorb Markers to fill space in the tissue or to improve cosmetic outcomes after procedures, or as a marker for radiation treatment.
  • Report any problems, complaints or complications experienced by patients after the placement of BioZorb Marker devices to the FDA.

For Facilities

  • Quarantine all products.
  • Share the notification with all surgeons who have used or plan to use the BioZorb Marker.
  • Identify product inventory affected by this action.
    • See the Customer Response Form Instructions included with the letter to identify affected products.
  • Confirm receipt of this communication by completing the online Customer Response Form even if there is no affected product in inventory.
    • Hologic will issue a Return Goods Authorization upon receipt of the Customer Response Form and will arrange for return of all affected products to the firm.
  • Forward a copy of the notice to other facilities or users who may have received affected product.

Reason for Recall

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

The use of affected product may cause serious adverse health consequences, including pain, infection, rash, device moving from where it was placed (migration), device breaking through the skin (erosion), fluid buildup under the skin (seroma), other complications and/or additional medical treatments, and death.

There have been 252 reported injuries. There have been no reports of death.

Device Use

The BioZorb Marker made by Hologic (previously Focal Therapeutics), is an implantable radiographic marker used to mark soft tissues (such as breast tissue) for future medical procedures.

The 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 is intended to be resorbed in the body after 1 year or longer. It is meant for one-time use.

Contact Information

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

Full List of Affected Devices

Part NumberPart DescriptionUDI(DI)
F0405BioZorb Marker 4cm x 5cm15420045514065
F0404BioZorb Marker 4cm x 4cm15420045514058
F0331BioZorb Marker 1cm x 3cm x 3cm15420045514041
F0231BioZorb Marker 1cm x 3cm x 2cm15420045514034
F0221BioZorb Marker 1cm x 3cm x 2cm15420045514027
F0304BioZorb Marker 3cm x 4cm15420045514010
F0303BioZorb Marker 3cm x 3cm15420045514003
F0203BioZorb Marker 2cm x 3cm15420045513990
F0202BioZorb Marker 2cm x 2cm15420045513983

Additional FDA Resources

Additional Company Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

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.

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