Z-2285-2010

Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100...

Name: Z-2285-2010 Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100...
Creator: Hologic, Inc.
Published: 2010-08-11
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2010-08-11 / Terminated / root cause: packaging

FDA source

Hologic, Inc. began a recall of Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The... on 2010-08-11. The reason FDA records is "The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20". 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-2285-2010
Status: Terminated
Initiated: 2010-08-11
Posted: 2010-08-26
Terminated: 2011-04-13
Recalling firm: Hologic, Inc.
Product: Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The handpiece is inserted into the breast to the site of interest. When the proper location/position is acheived, the handpiece cuts and removes biopsy tissue.
Product code: KNW Instrument, Biopsy
Reason for recall: The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm, Hologic, Inc., sent out "Urgent Medical Device Recall" letters by FedEx on August 11, 2010, to all customers. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to check their inventories and to quarantine any of the recalled product; if the product was distributed further, identify the users and notify them at once of this product recall; segregate all products from this lot and quarantine them in preparation for return to Hologic, and complete and return the enclosed RECALL RESPONSE FORM by fax at 877-574-3255 or mail. Note: Replacement product cannot be sent until Hologic receives your response form. If you have any questions, please contact Hologic directly at 317-344-7630.
Quantity in commerce: 990
Distribution: Worldwide distribution: USA and countries including Canada, Belgium, Algeria, Germany, London, Lebanon and Italy.
Product codes and lots: 00316.

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)