Reported May 15, 2024 · Ongoing
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405…
Hologic, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020
Is this the product you have?
9 of 9 products
| Model / number | Product as published |
|---|---|
F0405 | Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) |
F0404 | Marker 4cm x 5cm 2) |
F0331 | Marker 4cm x 4cm 3) |
F0231 | Marker 1cm x 3cm x 3cm 4) |
F0221 | Marker 1cm x 3cm x 2cm 5) |
F0304 | Marker 1cm x 3cm x 2cm 6) |
F0303 | Marker 3cm x 4cm 7) |
F0203 | Marker 3cm x 3cm 8) |
F0202 | Marker 2cm x 3cm 9) |
- Lot codes and dates
9 of 9 products
Products covered by this recall # Barcodes Product as published 1 15420045514065(1) 15420045514065 2 15420045514058(2) 15420045514058 3 15420045514041(3) 15420045514041 4 15420045514034(4) 15420045514034 5 15420045514027(5) 15420045514027 6 15420045514010(6) 15420045514010 7 15420045514003(7) 15420045514003 8 15420045513990(8) 15420045513990 9 15420045513983(9) 15420045513983. All lots, including implanted devices and non-implanted devices within expiration date. - Amount recalled
- 53492
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
Using this product could cause serious injury, illness or death — stop using it now.
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