Z-0275-2009

ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc...

Name: Z-0275-2009 ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc...
Creator: Hologic, Inc.
Published: 2008-09-22
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2008-09-22 / Terminated / root cause: manufacturing process

FDA source

Hologic, Inc. began a recall of ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Model number ATEC 1212-20. Intended for... on 2008-09-22. The reason FDA records is "The distal tip of the needle may become detached and remain in the patient, requiring surgical removal". 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-0275-2009
Status: Terminated
Initiated: 2008-09-22
Posted: 2008-11-07
Terminated: 2009-11-18
Recalling firm: Hologic, Inc.
Product: ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Model number ATEC 1212-20. Intended for partial or complete removal of tissue samples for diagnostic testing.
Product code: KNW Instrument, Biopsy
Reason for recall: The distal tip of the needle may become detached and remain in the patient, requiring surgical removal.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified via an Urgent Medical Device Recall letter dated 9/17/08 asking them to immediately check their inventories and quarantine all affected product from the listed lots. Also, if the product had been further distributed, users were to be identified and notified of the recall. Products are to be held in quarantine until they are returned to Hologic. The response form must be completed and returned to fulfill regulatory requirements and document actions taken at your facility. Handpieces whose pouches had been opened were to be destroyed, as they could potentially shift during transport and expose dangerous sharp points to personnel handling the boxes. Upon receipt of the attached response form, Hologic will promptly send an equivalent amount of replacement product free of charge.
Quantity in commerce: 5,120 (1,024 cases of 5)
Distribution: Worldwide Distribution --- including USA and countries of Australia, Belgium, Brazil and Singapore.
Product codes and lots: Lots 804038, 804050, 804067, 804085, 805049, 805054, 805064, 805080, 806004, 806016, 806051, 806066 and 806121.

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)