Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for u
FDA device recall Z-0362-2007 · posted 2007-01-23 · Terminated
Recall details
- Recalling firm
- Suros Surgical Systems Inc.
- Reason for recall
- The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.
- Action taken
- Consignees were notified by phone beginning on 12/15/06 and by follow-up letter dated 12/19/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 1249 handpieces
- Distribution
- Nationwide.
- Date initiated
- 2006-12-15
- Date posted
- 2007-01-23
- Date terminated
- 2007-05-04
- 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 |