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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-0964-04
Recall Event ID 28998
510(K)Number K013860  
Product Classification Staple, Implantable - Product Code GDW
Product Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 4.8mm DST Series
Ref: TA6048S
Code Information LOT # P2H15 P2J240 P2J240A P2J265 P2J784 P2J786 P2K827 P2L124 P2L655 P2L656 P2M96 P3A418 P3A648 P3A940 P3A98 P3C01 P3C423 P3C626 P3D21 P3D280 P3D584 P3D951 P3F468 P3G914 P3H249 P3H444R P3H566 P3J238 P3J462 P3J463 P3L1149 P3L1150 P3L229 P3L230 P3L240 P3L241 P3L458 P3L459 P3L460 P3L638 P3L730 P3L994 P3L995 P3L996 P4A138 P4A889 P4B270 P4B591 P4B714 P4B716 U2E13R U2F08 U2F28 U2F30 
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