ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Mode

FDA device recall Z-0275-2009 · posted 2008-11-07 · Terminated

Recall details

Recalling firm

Hologic, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

KNW

Quantity affected

5,120 (1,024 cases of 5)

Distribution

Worldwide Distribution --- including USA and countries of Australia, Belgium, Brazil and Singapore.

Date initiated

2008-09-22

Date posted

2008-11-07

Date terminated

2009-11-18

Location

Indianapolis, IN

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