Hologic, Inc. withdraws BioZorb tracer due to complications related to implanted devices

May 22, 2024 – The U.S. Food and Drug Administration (FDA) has recalled Hologic Inc. BioZorb marker due to complications related to implanted devices. The agency described it as a Class I recall, the most serious type of recall. Details are provided in a written notice issued by the FDA on May 22 and made available here.

The U.S. Food and Drug Administration (FDA) classified it as a Class I recall, the most serious type of recall. Use of these devices may result in serious injury or death. Details regarding the recall were published in a written notice issued by the FDA and are available in full here.

Please note that this recall is a correction, not a product removal.

Product discontinued

Product name: BioZorba tag

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 US: 53,492

Company initiation date: March 13, 2024

Using the device

The BioZorb marker from Hologic (formerly Focal Therapeutics) is an implantable radiographic marker used to mark soft tissues (such as breast tissue) for future medical procedures such as radiation therapy. The device consists of two elements: a permanent element made of metallic titanium and an absorbable element made of plastic that becomes absorbed over time. It is supplied sterile and intended for single use.

Reason for withdrawal

Hologic, Inc. recalls Biozorb Marker due to complications and adverse events reported with implanted devices. Complaints included reports of pain, infection, rash, device migration, device erosion, serous hematoma formation, discomfort or other complications related to the sensation of the device in the breast, and the need for additional treatment to remove the device.

71 injuries were reported and there were no reports of deaths.

To whom it may concern

– People who have had the BioZorb tag implanted.

– People receiving radiation based on the BioZorb tag who may have migrated.

– People undergoing systemic cancer treatment may experience a delay in their treatment due to complications associated with the use of BioZorb Marker.

– Radiologists, surgeons, oncologists and other healthcare professionals who use the BioZorb Marker to treat their patients.

What to do

On March 13, 2024, Hologic, Inc. has sent all affected customers an important medical device safety notice.

The letter asked patients to:

– Contact your doctor if you experience any side effects after having the BioZorb tag placed.

-Discuss the benefits and possible risks of using implantable breast tissue markers for breast cancer procedures with your doctor.

– Report any problems or complications that arise after placing BioZorb Marker devices to Hologic at (email protected) and to the FDA’s MedWatch adverse event reporting program.

-Discuss the benefits and possible risks of using implantable breast tissue markers for breast cancer procedures with your doctor.

The letter asked healthcare providers to:

– Please be aware of reports of serious adverse events following the placement of BioZorb Marker devices in breast tissue.

– Discuss the benefits and possible risks of using BioZorb Marker devices with each patient.

– Inform all patients which device will be used if a marking device is used during breast conserving surgery.

-Continue to monitor patients implanted with the BioZorb Marker for signs of any side effects.

– Any problems or complications patients experience after placement of BioZorb Marker devices should be reported to Hologic

Complaints can be submitted to (email protected) and to the FDA’s MedWatch adverse event reporting program.

Contact info

U.S. customers with questions regarding this recall should contact Hologic, Inc. at: (email protected).

Additional resources

BioZorb LP Class 1 Device Recall Marker (fda.gov)

BioZorb Markers and Potential Risks Associated with Use in Breast Tissue: FDA Safety Notice | FDA

How to report a problem?

Healthcare professionals and consumers can report adverse events or quality issues they experience while using these devices to MedWatch: FDA’s Safety and Adverse Event Reporting Program using an online form, mail or fax.