FDA Medical Device Recalls (openFDA)
Suros Surgical Systems Inc.: ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.
- Recall number
- Z-1160-06
- Recalling firm
- Suros Surgical Systems Inc.
- Product
- ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.
- Status
- Terminated
- Initiated
- 2006-05-25
- Posted
- 2006-06-22
- Terminated
- 2007-03-12
- Reason
- Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).
- Root cause
- Other
- Action
- Consignees were notified telephone and letter dated 5/25/06 to stop using the recalled product and to return it to the firm. The recall was extended to an additional lot by phone calls to each customer between Julne 26 and 30, 2006 and by letter dated 6/19/06 and sent between June 28 and July 7, 2006.
- Quantity
- 939
- Distribution
- Nationwide.
- Lot, serial or model codes
- Needle guide lot numbers 603006, exp. 3/1/2008, and 602013, exp. 2/6/2008.
- 510(k) numbers
- ["K010400"]
- 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