Device recall
Z-1160-2010: ATEC 0909-12 Breast Biopsy and Excision System, 9 gauge, 9 centimeter handpiece…
FDA device recall · Class III · Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-1160-2010 |
|---|---|
| Recall event | 54619 |
| Product | ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278. The handpiece is inserted into the breast to the site of the area of interest. When the proper… |
| Product code | KNW |
| Recalling firm | Hologic, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 8, 2010 |
| 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