ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Sur
FDA device recall Z-1160-2010 · posted 2010-03-18 · Terminated
Recall details
- Recalling firm
- Hologic, Inc.
- Reason for recall
- The product is labeled as ATEC0909-12 but it actually contains 0909-20.
- Action taken
- Formal recall notification letters and response forms were sent to customers via FEDEX on February 1, 2010. If there are any questions, please call 317.344.7630.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 190
- Distribution
- US and Puerto Rico.
- Date initiated
- 2010-02-01
- Date posted
- 2010-03-18
- Date terminated
- 2010-10-08
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACUUM ASSISTED CORE BIOPSY DEVICE (K042290) | Suros Surgical Systems, Inc. | 2004-10-06 |
| VACUUM ASSISTED CORE BIOPSY DEVICE (K010400) | Promex, Inc. | 2001-07-24 |