Class 2 Device Recall ATEC 091220 Handpiece

• Date Initiated by Firm: August 11, 2010
• Date Posted: August 26, 2010
• Recall Status: Terminated on April 13, 2011
• Recall Number: Z-2285-2010
• Recall Event ID: 56542
• 510(K)Number: K042290 K010400
• Product Classification: Instrument, biopsy - Product Code KNW
• Product: 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: 00316.
• Recalling Firm/ Manufacturer: Hologic, Inc.; 6100 Technology Center Dr; Indianapolis IN 46278-6016
• For Additional Information Contact: Heidi Strunk; 317-344-7500
• Manufacturer Reason for Recall: The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.
• FDA Determined Cause: Packaging
• Action: 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.
• Quantity in Commerce: 990
• Distribution: Worldwide distribution: USA and countries including Canada, Belgium, Algeria, Germany, London, Lebanon and Italy.
• 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.