Z-1160-2010

ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx...

Name: Z-1160-2010 ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx...
Creator: Hologic, Inc.
Published: 2010-02-01
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2010-02-01 / Terminated / root cause: manufacturing process

FDA source

Hologic, Inc. began a recall of ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100... on 2010-02-01. The reason FDA records is "The product is labeled as ATEC0909-12 but it actually contains 0909-20". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1160-2010
Status: Terminated
Initiated: 2010-02-01
Posted: 2010-03-18
Terminated: 2010-10-08
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.
Product code: KNW Instrument, Biopsy
Reason for recall: The product is labeled as ATEC0909-12 but it actually contains 0909-20.
Root cause tag: manufacturing process
FDA 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 in commerce: 190
Distribution: US and Puerto Rico.
Product codes and lots: 910058

Product code KNW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)