FDA recall Z-0328-2025

Product

BioZorb Marker. Radiographic soft tissue marker.

Reason for recall

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

Distribution

Domestic: US Nationwide Distribution.

Key facts

Status

Ongoing

Initiation date

2024-10-10

Report date

2024-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0328-2025