Device recall
Z-0275-2009: ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece…
FDA device recall · Class II · Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-0275-2009 |
|---|---|
| Recall event | 49602 |
| Product | ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Model number ATEC 1212-20. Intended for partial or complete removal of tissue samples for diagnostic testing. |
| Product code | KNW |
| Recalling firm | Hologic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2009 |
| 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