Device recall
Z-2285-2010: Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12…
FDA device recall · Class II · Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-2285-2010 |
|---|---|
| Recall event | 56542 |
| Product | Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The handpiece is inserted into the breast to the site of interest. When the proper location/position is acheived, the handpiece cuts and removes… |
| Product code | KNW |
| Recalling firm | Hologic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 13, 2011 |
| 510(k) numbers | K010400, K042290 |
| FEI number | 3003862400 |
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