Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall ATEC 090912 handpiece

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall ATEC 090912 handpiece see related information
Date Initiated by Firm February 01, 2010
Date Posted March 18, 2010
Recall Status1 Terminated 3 on October 08, 2010
Recall Number Z-1160-2010
Recall Event ID 54619
510(K)Number K042290  K010400  
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 2		 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 and Original Applicant = PROMEX, INC.
510(K)s with Product Code = KNW and Original Applicant = SUROS SURGICAL SYSTEMS, INC.
-
-