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U.S. Department of Health and Human Services

Class 1 Device Recall BioZorb LP Marker

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 Class 1 Device Recall BioZorb LP Markersee related information
Date Initiated by FirmMarch 13, 2024
Date PostedMay 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1733-2024
Recall Event ID 94359
510(K)NumberK152070 
Product Classification Marker, radiographic, implantable - Product Code NEU
ProductBioZorb 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 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.
Recalling Firm/
Manufacturer		 Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
For Additional Information ContactBreast & Skeletal Health Customer Support - Customer Support
800-442-9892 Ext. 2
Manufacturer 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
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionHologic 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
Quantity in Commerce53492
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NEU
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