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

FDA device recall Z-2285-2010 · posted 2010-08-26 · Terminated

Recall details

Recalling firm

Hologic, Inc.

Reason for recall

The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.

Action taken

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

Status

Terminated

Product code

KNW

Quantity affected

990

Distribution

Worldwide distribution: USA and countries including Canada, Belgium, Algeria, Germany, London, Lebanon and Italy.

Date initiated

2010-08-11

Date posted

2010-08-26

Date terminated

2011-04-13

Location

Indianapolis, IN

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