Device recall
Z-1733-2024: BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking…
FDA device recall · Class I · Hologic, Inc
Key facts
| Recall number (Z-number) | Z-1733-2024 |
|---|---|
| Recall event | 94359 |
| Product | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6)… |
| Product code | NEU |
| Recalling firm | Hologic, Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K152070 |
| FEI number | 1000120743 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database