Device recall
Z-2035-2023: Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy…
FDA device recall · Class II · Hologic, Inc
Key facts
| Recall number (Z-number) | Z-2035-2023 |
|---|---|
| Recall event | 92357 |
| Product | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14 |
| Product code | KNW |
| Recalling firm | Hologic, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150169 |
| FEI number | 1000120743 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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