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ATEC Breast Biopsy and Excision System 12 gauge, 20… recallZ-0275-2009 · Hologic, Inc. · initiated Sep 22, 2008

Terminated All recalls posted in November 2008

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 distal tip of the needle may become detached and remain in the patient, requiring surgical removal.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0275-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 22, 2008
Posted by the FDA
Nov 7, 2008
Recalling firm
Hologic, Inc.
Quantity
5,120 (1,024 cases of 5)
Product code
KNW
FDA submissions
K010400, K042290
Distribution
Worldwide Distribution --- including USA and countries of Australia, Belgium, Brazil and Singapore.

Product description

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.

Code information (models, lots, serial numbers)

Lots 804038, 804050, 804067, 804085, 805049, 805054, 805064, 805080, 806004, 806016, 806051, 806066 and 806121.

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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