FDA Medical Device Recalls (openFDA)
Hologic, Inc.: ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278. The handpiece is inserted into the breast to the site of the area of interest. When the proper location/[position is achieved, the handpiece cuts and removes biopsy tissue.
- Recall number
- Z-1160-2010
- Recalling firm
- Hologic, Inc.
- Product
- ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278. The handpiece is inserted into the breast to the site of the area of interest. When the proper location/[position is achieved, the handpiece cuts and removes biopsy tissue.
- Status
- Terminated
- Initiated
- 2010-02-01
- Posted
- 2010-03-18
- Terminated
- 2010-10-08
- Reason
- The product is labeled as ATEC0909-12 but it actually contains 0909-20.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 190
- Distribution
- US and Puerto Rico.
- Lot, serial or model codes
- 910058
- 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