FDA Medical Device Recalls (openFDA)
Suros Surgical Systems Inc.: Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.
- Recall number
- Z-0362-2007
- Recalling firm
- Suros Surgical Systems Inc.
- Product
- Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.
- Status
- Terminated
- Initiated
- 2006-12-15
- Posted
- 2007-01-23
- Terminated
- 2007-05-04
- Reason
- The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.
- Root cause
- Other
- Action
- Consignees were notified by phone beginning on 12/15/06 and by follow-up letter dated 12/19/06.
- Quantity
- 1249 handpieces
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot 611018.
- 510(k) numbers
- ["K010400","K042290"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 3003862400
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28