BioZorb recallZ-1733-2024 · Hologic, Inc · initiated Mar 13, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
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 [email protected] 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 [email protected] and to the FDA s MedWatch Adverse Event Reporting program. If you have any questions about this communication, please contact [email protected]. ***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
Recall details
- Recall number
- Z-1733-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 13, 2024
- Posted by the FDA
- May 3, 2024
- Recalling firm
- Hologic, Inc
- Quantity
- 53492
- Product code
- NEU
- FDA submissions
- K152070
- Distribution
- US Nationwide Distribution
Product description
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm
Code information (models, lots, serial numbers)
UDI-DI: (1) 15420045514065; (2) 15420045514058; (3) 15420045514041; (4) 15420045514034; (5) 15420045514027; (6) 15420045514010; (7) 15420045514003; (8) 15420045513990; (9) 15420045513983. All lots, including implanted devices and non-implanted devices within expiration date.
Devices named in this recall
9 devices in the FDA device registry whose identifier appears in the recall's code information.
- BioZorb F0202Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls192 reports
- BioZorb F0221Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE3 recalls15 reports
- BioZorb F0203Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls51 reports
- BioZorb F0303Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0304Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0231Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0404Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls6 reports
- BioZorb F0331Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls4 reports
- BioZorb F0405Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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