BioZorb Marker. Radiographic soft tissue marker.
Reported: December 4, 2024 Initiated: October 10, 2024 #Z-0328-2025
Product Description
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.
Details
- Recalling Firm
- Hologic, Inc
- Units Affected
- 12,710 units
- Distribution
- Domestic: US Nationwide Distribution.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
BioZorb Marker. Radiographic soft tissue marker.. Recalled by Hologic, Inc. Units affected: 12,710 units.
Why was this product recalled? ▼
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2024. Severity: Critical. Recall number: Z-0328-2025.
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