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.
FDA Recall Z-2285-2010 · Posted 2010-08-26
Recalling FirmHologic, Inc.
Recall StatusTerminated
Product CodeKNW
Date Initiated2010-08-11
Date Terminated2011-04-13
Product Quantity990
Reason for Recall
The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Worldwide distribution: USA and countries including Canada, Belgium, Algeria, Germany, London, Lebanon and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.