ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9… recallZ-1160-2010 · Hologic, Inc. · initiated Feb 1, 2010
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product is labeled as ATEC0909-12 but it actually contains 0909-20.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1160-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 1, 2010
- Posted by the FDA
- Mar 18, 2010
- Recalling firm
- Hologic, Inc.
- Quantity
- 190
- Product code
- KNW
- FDA submissions
- K010400, K042290
- Distribution
- US and Puerto Rico.
Product description
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.
Code information (models, lots, serial numbers)
910058
Other devices under the same FDA submission
15 devices cleared under K010400, K042290 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ATEC 0912-20Hologic, Inc. · INSTRUMENT, BIOPSY32 reports
- ATEC SAPPHIRE 100Hologic, Inc. · INSTRUMENT, BIOPSY25 reports
- ATEC SAPPHIREHologic, Inc. · INSTRUMENT, BIOPSY18 reports
- ATEC 0914-20MRHologic, Inc. · INSTRUMENT, BIOPSY17 reports
- ATEC Introducer ILS 0914-20Hologic, Inc. · INSTRUMENT, BIOPSY13 reports
- ATEC PEARLHologic, Inc. · INSTRUMENT, BIOPSY8 reports
- ATEC 1212-20Hologic, Inc. · INSTRUMENT, BIOPSY7 reports
- ATEC SAPPHIRE25Hologic, Inc. · INSTRUMENT, BIOPSY5 reports
- ATEC Introducer ILS 0914-12Hologic, Inc. · INSTRUMENT, BIOPSY4 reports
- ATEC Sapphire 200Hologic, Inc. · INSTRUMENT, BIOPSY2 reports
- ATEC 0909-20Hologic, Inc. · INSTRUMENT, BIOPSY2 reports
- ATEC 0912-12Hologic, Inc. · INSTRUMENT, BIOPSY2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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