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Suros ATEC 0912-20 Breast Biopsy and Excision System… recallZ-2285-2010 · Hologic, Inc. · initiated Aug 11, 2010

Terminated All recalls posted in August 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging

What the company is doing

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.

Recall details

Recall number
Z-2285-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 11, 2010
Posted by the FDA
Aug 26, 2010
Recalling firm
Hologic, Inc.
Quantity
990
Product code
KNW
FDA submissions
K010400, K042290
Distribution
Worldwide distribution: USA and countries including Canada, Belgium, Algeria, Germany, London, Lebanon and Italy.

Product description

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.

Code information (models, lots, serial numbers)

00316.

Other devices under the same FDA submission

15 devices cleared under K010400, K042290 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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