Design and manufacturing flaws in BioZorb devices, inadequate quality controls, and delayed responses to safety complaints. Calls for a comprehensive corrective plan within 15 business days to ...

Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even though the company recalled the devices last year.

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.

Rishell accused the company of negligently designing, manufacturing and marketing the BioZorb device. The device is used to assist in radiation treatment of breast cancer by identifying breast ...

The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...

Marlborough-based medical device manufacturer Hologic has been issued a warning letter from the U.S. Food and Drug Administration concerning its BioZorb Marker, a device originally recalled in March.

Also, BioZorb 3D Bioabsorbable Markers were withdrawn from the market following reports of serious adverse events occurring in patients who had the devices implanted in breast tissue. Furthermore ...

The Biozorb devices were implanted in breast tissue to mark tumor excision sites for monitoring or future treatments. They consist of a plastic component intended to dissolve into patients’ bodies and ...