Z-0362-2007

Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter...

Name: Z-0362-2007 Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter...
Creator: Suros Surgical Systems Inc.
Published: 2006-12-15
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2006-12-15 / Terminated / root cause: packaging

FDA source

Suros Surgical Systems Inc. began a recall of Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and... on 2006-12-15. The reason FDA records is "The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle". 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-0362-2007
Status: Terminated
Initiated: 2006-12-15
Posted: 2007-01-23
Terminated: 2007-05-04
Recalling firm: Hologic, Inc.
Product: Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.
Product code: KNW Instrument, Biopsy
Reason for recall: The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were notified by phone beginning on 12/15/06 and by follow-up letter dated 12/19/06.
Quantity in commerce: 1249 handpieces
Distribution: Nationwide.
Product codes and lots: Lot 611018.

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