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U.S. Department of Health and Human Services

Class 2 Device Recall ATEC

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  Class 2 Device Recall ATEC see related information
Date Initiated by Firm May 25, 2006
Date Posted June 22, 2006
Recall Status1 Terminated 3 on March 12, 2007
Recall Number Z-1160-06
Recall Event ID 35552
510(K)Number K010400  
Product Classification Needle Guide Breast Biopsy and Excision - Product Code KNW
Product ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.
Code Information Needle guide lot numbers 603006, exp. 3/1/2008, and 602013, exp. 2/6/2008.  
Recalling Firm/
Manufacturer		 Suros Surgical Systems Inc.
6100 Technology Center Dr
Indianapolis IN 46278-6016
For Additional Information Contact
317-344-7630
Manufacturer Reason
for Recall		 Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).
FDA Determined
Cause 2		 Other
Action Consignees were notified telephone and letter dated 5/25/06 to stop using the recalled product and to return it to the firm. The recall was extended to an additional lot by phone calls to each customer between Julne 26 and 30, 2006 and by letter dated 6/19/06 and sent between June 28 and July 7, 2006.
Quantity in Commerce 939
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.
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