October 24, 2024
URGENT: MEDICAL DEVICE RECALL
BioZorb® 3D Bioabsorbable Marker
Dear Valued Hologic Customer,
Hologic Inc., would like to inform patients and health care providers that it is voluntarily removing all lots of unused BioZorb Marker and BioZorb LP Marker (BioZorb Marker) from the market.
The BioZorb Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures. The BioZorb Marker is an implantable radiographic marker not indicated to improve cosmetic outcomes after procedures or fill space in the tissue, and not indicated to be marked for radiation treatment.
On February 27, 2024, Hologic alerted health care providers about possible health risks reported with respect to the BioZorb Marker implantable devices. (https://www.hologic.com/biozorb-3d-bioabsorbable-marker/important-safety-information). This notification is different than the safety notification sent in February. Hologic is now requesting all lots of unused BioZorb Markers to be returned.
As stated in our safety notification sent in February, Hologic has received patient complaints that described complications/adverse events that include serious injuries such as pain, infection, rash, device migration, device erosion, seroma, discomfort, and/or other complications from feeling the device in the breast, and in some limited instances, additional medical treatment.
Out of 91,531 number of devices sold since 2015, there have been 399 complaints and out of which 188 were associated with adverse events as of October 16, 2024. As a cautionary measure, Hologic is requesting all lots of unused BioZorb Markers to be returned
Instructions for Facilities
Quarantine products at your facility.
This notification should be shared with all surgeons in your practice that have or planned to use the BioZorb Marker.
Refer to the Customer Response Form Instructions to identify your product inventory that is subject to this action.
Confirm receipt of this communication by completing the online Customer Response Form. Please complete and submit the online Customer Response Form even if you no longer have the affected product in inventory.
If the affected product has been distributed to another user or location, please forward a copy of the notice as needed.
Hologic will issue a Return Goods Authorization upon receipt of the Customer Response Form and the return of all affected products to Hologic
Recommendations for Patients
If you experience any adverse events following the placement of your BioZorb Marker, please contact your health care provider.
Report any problems or complications experienced following the placement of BioZorb Marker devices to Hologic at breasthealth.support@hologic.com and to the FDA’s MedWatch Adverse Event Reporting program.
There is no need to undergo explantation of the device unless advised by your healthcare provider.
If you have received the BioZorb Marker and/or your provider is planning radiation therapy treatments, discuss the possible risks with your provider.
Recommendations for Health Care Providers
Be aware of reports of serious adverse events following the placement of the BioZorb Marker devices in breast tissue.
Continue to monitor patients who have an implanted BioZorb Marker for signs of any adverse events.
BioZorb Markers are not cleared to fill space in the tissue or to improve cosmetic outcomes after procedures.
Report any problems or complications experienced by patients following placement of the BioZorb Marker devices to Hologic. Complaints can be submitted to breasthealth.support@hologic.com and to the FDA’s MedWatch Adverse Event Reporting program.
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.
You can find the affected BioZorb Marker devices by checking the UDI table below. The UDI is a unique numeric or alphanumeric code that generally includes a Device Identifier (DI) that identifies the labeler and the specific version or model of a device, as well as a Production Identifier (PI) that identifies additional information, which may include lot number, serial number, expiration date, and manufactured date.
Hologic has notified and is working closely with the FDA concerning the voluntary product removal.
Our goal is first and always to provide high-quality products that enable our customers to provide safe, effective patient care to their patients. We are committed to providing you with the most accurate and up-to-date information and ensuring the ongoing safety and efficacy of our products.
If you have any questions about this communication, please contact breasthealth.support@hologic.com.