Device recall
Z-1858-2022: The BioZorb LP Marker is an implantable radiopaque marker used to facilitate…
FDA device recall · Class II · Hologic, Inc
Key facts
| Recall number (Z-number) | Z-1858-2022 |
|---|---|
| Recall event | 90734 |
| Product | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP… |
| Product code | NEU |
| Recalling firm | Hologic, Inc |
| Recall class | Class II |
| 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