Approximately 53,492 BioZorb 3D Bioabsorbable Markers are being recalled after reports of serious complications including device migration, erosion, and infection. These markers, implanted in breast tissue to mark surgical sites, have caused some patients to experience pain, rashes, and the development of fluid-filled sacs called seromas. In some cases, additional medical procedures were required to surgically remove the device because it was causing significant discomfort or other health issues. This recall affects all lots of various sizes including 4cm x 5cm, 3cm x 4cm, and 2cm x 2cm models.
The implanted markers can shift from their original position or break through tissue, leading to localized infections, persistent pain, and the need for invasive surgery to remove the device. Patients may feel the device through the skin, causing physical discomfort and skin irritation.
Consultation and potential medical removal
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.