Class 3 Device Recall ATEC 090912 handpiece

• Date Initiated by Firm: February 01, 2010
• Date Posted: March 18, 2010
• Recall Status: Terminated on October 08, 2010
• Recall Number: Z-1160-2010
• Recall Event ID: 54619
• 510(K)Number: K010400 K042290
• Product Classification: Vacuum assisted core biopsy device - Product Code KNW
• Product: ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278. The handpiece is inserted into the breast to the site of the area of interest. When the proper location/[position is achieved, the handpiece cuts and removes biopsy tissue.
• Code Information: 910058
• Recalling Firm/ Manufacturer: Hologic, Inc.; 6100 Technology Center Dr; Indianapolis IN 46278-6016
• For Additional Information Contact: Heidi Hancock Strunk; 317-344-7500
• Manufacturer Reason for Recall: The product is labeled as ATEC0909-12 but it actually contains 0909-20.
• FDA Determined Cause: Employee error
• Action: Formal recall notification letters and response forms were sent to customers via FEDEX on February 1, 2010. If there are any questions, please call 317.344.7630.
• Quantity in Commerce: 190
• Distribution: US and Puerto Rico.
• 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; 510(K)s with Product Code = KNW