Z-1160-06

ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09

Name: Z-1160-06 ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09
Creator: Suros Surgical Systems Inc.
Published: 2006-05-25
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2006-05-25 / Terminated / root cause: packaging

FDA source

Suros Surgical Systems Inc. began a recall of ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09 on 2006-05-25. The reason FDA records is "Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1160-06
Status: Terminated
Initiated: 2006-05-25
Posted: 2006-06-22
Terminated: 2007-03-12
Recalling firm: Hologic, Inc.
Product: ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.
Product code: KNW Instrument, Biopsy
Reason for recall: Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).
Root cause tag: packaging
FDA 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 in commerce: 939
Distribution: Nationwide.
Product codes and lots: Needle guide lot numbers 603006, exp. 3/1/2008, and 602013, exp. 2/6/2008.

Product code KNW

K010400Class IIVacuum Assisted Core Biopsy DevicePromex, Inc. / cleared 2001-07-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)