Class 2 Device Recall ATEC Breast Biopsy and Excision System

• Date Initiated by Firm: September 22, 2008
• Date Posted: November 07, 2008
• Recall Status: Terminated on November 18, 2009
• Recall Number: Z-0275-2009
• Recall Event ID: 49602
• 510(K)Number: K042290 K010400
• Product Classification: Biopsy Instrument - Product Code KNW
• Product: 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: Lots 804038, 804050, 804067, 804085, 805049, 805054, 805064, 805080, 806004, 806016, 806051, 806066 and 806121.
• Recalling Firm/ Manufacturer: Hologic, Inc.; 9502 Angola Ct Ste 3; Indianapolis IN 46268-3178
• For Additional Information Contact: 800-650-2169
• Manufacturer Reason for Recall: The distal tip of the needle may become detached and remain in the patient, requiring surgical removal.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 5,120 (1,024 cases of 5)
• Distribution: Worldwide Distribution --- including USA and countries of Australia, Belgium, Brazil and Singapore.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KNW and Original Applicant = PROMEX, INC.; 510(K)s with Product Code = KNW and Original Applicant = SUROS SURGICAL SYSTEMS, INC.