FDA Announces Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers Due To Risk For Patient Complications

Benzinga · Dec 19 01:24

Thisrecallinvolves removing devices from where they are used or sold.The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

Product Names: BioZorb Marker and BioZorb LP Marker
Product Codes: NEU
Product Part Numbers:
- F0405 BioZorb Marker 4cm x 5cm
- F0404 BioZorb Marker 4cm x 4cm
- F0331 BioZorb Marker 1cm x 3cm x 3cm
- F0231 BioZorb Marker 1cm x 3cm x 2cm
- F0221 BioZorb Marker 1cm x 3cm x 2cm
- F0304 BioZorb Marker 3cm x 4cm
- F0303 BioZorb Marker 3cm x 3cm
- F0203 BioZorb Marker 2cm x 3cm
- F0202 BioZorb Marker 2cm x 2cm
Product Description and UDI:
- See full list of affected devices.
Lot numbers: All unused lot numbers

What...

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FDA Announces Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers Due To Risk For Patient Complications

Affected Product

What...

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