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U.S. Department of Health and Human Services

Class 2 Device Recall Suros ATEC Breast Biopsy System

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  Class 2 Device Recall Suros ATEC Breast Biopsy System see related information
Date Initiated by Firm December 15, 2006
Date Posted January 23, 2007
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = PROMEX, INC.
510(K)s with Product Code = KNW and Original Applicant = SUROS SURGICAL SYSTEMS, INC.
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