Class 2 Device Recall Suros ATEC Breast Biopsy System

• Date Initiated by Firm: December 15, 2006
• Date Posted: January 23, 2007
• Recall Status: Terminated on May 04, 2007
• Recall Number: Z-0362-2007
• Recall Event ID: 37071
• 510(K)Number: K042290 K010400
• Product Classification: biopsy system - Product Code KNW
• Product: Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.
• Code Information: Lot 611018.
• FEI Number: 3003862400
• Recalling Firm/ Manufacturer: Suros Surgical Systems Inc.; 6100 Technology Center Dr; Indianapolis IN 46278-6016
• For Additional Information Contact: Heidi Strunk; 317-344-7630
• Manufacturer Reason for Recall: The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.
• FDA Determined Cause: Other
• Action: Consignees were notified by phone beginning on 12/15/06 and by follow-up letter dated 12/19/06.
• Quantity in Commerce: 1249 handpieces
• Distribution: Nationwide.
• 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