Device recall
Z-1041-2023: Mammotome MammoStar Biopsy Site Identified, REF STAR1401
FDA device recall · Class II · Carbon Medical Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-1041-2023 |
|---|---|
| Recall event | 91419 |
| Product | Mammotome MammoStar Biopsy Site Identified, REF STAR1401 |
| Product code | NEU |
| Recalling firm | Carbon Medical Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 9, 2023 |
| 510(k) numbers | K100994 |
| FEI number | 3002619738 |
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