FDA-Device2024-12-04Class I
BioZorb Marker. Radiographic soft tissue marker.
Hologic, Inc
Hazard
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Sold states
Domestic: US Nationwide Distribution.
Affected count
12,710 units
Manufactured in
250 Campus Dr, Marlborough, MA, United States
Products
BioZorb Marker. Radiographic soft tissue marker.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0328-2025Don't want to check this manually?
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