BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZo

FDA device recall Z-1733-2024 · posted 2024-05-03 · Open, Classified

Recall details

Recalling firm

Hologic, Inc

Reason for recall

Safety Information: Complaints describe complications/adverse events that include 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

Action taken

Hologic issued Medical Device Safety Notification on 3/13/24 via Certified Mail. Letter states reason for notification, health risk and action to take: This notification should be shared with all surgeons in your practice that have or will use the BioZorb Marker. Recommendations for Patients " If you experience any adverse events following the placement of your BioZorb Marker, please contact your health care provider. " Discuss the benefits and possible risks of implantable breast tissue markers for breast cancer procedures with 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. Recommendations for Health Care Providers " Be aware of reports of serious adverse events following the placement of the BioZorb Marker devices in breast tissue. " Discuss the benefits and possible risks of BioZorb Marker devices with your patient. " Continue to monitor patients who have an implanted BioZorb Marker for signs of any adverse events. " BioZorb Marker and BioZorb LP Marker are not cleared to fill space in the tissue or to improve cosmetic outcomes after procedures. " Inform your patient which device you plan to use, if you plan to implant a marking device during breast conservation surgery. " 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. If you have any questions about this communication, please contact breasthealth.support@hologic.com. ***Update 10/7/2024*** On 9/5/2024 6 consignees were notified who received product since the initial letter was sent. This notification should be shared with all surgeons in your practice that have or will use the BioZorb Marker. Recommendations for Patients: " If you

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

NEU

Quantity affected

53492

Distribution

US Nationwide Distribution

Date initiated

2024-03-13

Date posted

2024-05-03

Location

Marlborough, MA

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