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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 Recall
Suros ATEC Breast Biopsy System
see related information
Date Posted January 23, 2007
Recall Status1 Terminated on May 04, 2007
Recall Number Z-0362-2007
Recall Event ID 37071
Premarket Notification
510(K) Numbers
K010400  K042290 
Product Classification Instrument, Biopsy - 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, Indiana 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
DESIGN: Labeling Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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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