Recall Z-0328-2025 ยท NEU Marker, Radiographic, Implantable
Hologic, Inc
BioZorb Marker. Radiographic soft tissue marker.
| Date | Nov 26, 2024 (initiated Oct 10, 2024) |
| Status | Open, Classified |
| Reason | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. |
| Root cause | Device Design |
| Action | Consignees were sent an URGENT: MEDICAL DEVICE RECALL letter by mail dated 10/24/24. The notification instructs consignees to quarantine all affected devices and share the recall notification with all surgeons in their practice that have used or planned to use the BioZorb Marker. Additionally, if product was further distributed the notice is to be forwarded to those customers. Affected devices will be returned to Hologic and coordination of return will be initiated by return of the Customer Response Form. Healthcare providers are recommended to be aware of reports of serious adverse events f |
| Quantity | 12,710 units |
| Distribution | Domestic: US Nationwide Distribution. |
| FDA record | Open on fda.gov |