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U.S. Department of Health and Human Services

Class 2 Device Recall United States Surgical

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  Class 2 Device Recall United States Surgical see related information
Date Initiated by Firm May 05, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 15, 2006
Recall Number Z-0958-04
Recall Event ID 28998
510(K)Number K013860  
Product Classification Staple, Implantable - Product Code GDW
Product Auto Suture TA 30 Reloadable Staplers, Single Patient Use
Ref TA30V3S, V3 (2.5mm) DST Series
Code Information LOT# P2J507 P2J972 P2K1034 P2K616 P2L334 P2L335 P2L607 P2M694 P2M695 P3A83 P3B307 P3D245 P3D564 P3E236 P3E309 P3F683 P3G300 P3G855 P3H21 P3J263 P3J408 P3J42 P3K13 P3L1011 P3L1012 P3L1133 P3L1134 P3L13 P3L237 P3L447 P3L628 P3L728 P3M558 P3M668 P4A636 P4B176 U2H11 U2H17 U2J01 U2J02 
Recalling Firm/
United States Surgical
195 Mcdermott Rd
North Haven CT 06473-3665
For Additional Information Contact Garry Raymond
Manufacturer Reason
for Recall
Stapler may clamp without the staples being fired into the tissue
FDA Determined
Cause 2
Action United States Surgical notiied direct accounts by letter dated 5/5/04. Accounts are requested to inventory and quarantine product for return to USS.
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 = GDW and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC