Hologic, Inc. is recalling 12,710 units of the BioZorb Marker, a radiographic soft tissue marker used during surgical procedures. The manufacturer initiated the recall after receiving reports of adverse events including serious injuries and clinical complications at the implant site. Reported issues include pain, infection, rash, and the device moving from its original position or eroding through tissue. Healthcare facilities are advised to stop using the marker, and patients who have received this implant should contact their healthcare provider if they experience discomfort or symptoms of infection.
The marker can migrate, erode through surrounding tissue, or cause infections and fluid buildup (seroma), which can result in chronic pain and may require additional medical procedures to address the injury. There have been several reports of serious injuries including pain, rash, and infection related to these device complications.
Recall encompasses approximately 12,710 units distributed nationwide.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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