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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-0961-04
Recall Event ID 28998
510(K)Number K013860  
Product Classification Staple, Implantable - Product Code GDW
Product Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 3.5mm DST Series
Ref: TA4535S
Code Information LOT# P2J450 P2J795 P2J796 P2J797 P2J798 P2L657 P2M193 P2M241 P2M542 P2M98 P3A412 P3A91 P3A92 P3A93 P3B345 P3B608 P3B609 P3B610 P3C238 P3D246 P3D568 P3D947 P3E237 P3E300 P3E523 P3F113 P3F684 P3G960 P3J237 P3J43 P3J44 P3J459 P3J711 P3K15 P3L1135 P3L1136 P3L1152 P3L235 P3L236 P3L448 P3L449 P3L629 P3L997 P3L998 P3M672 P3M673 P4A554 P4A637 P4A883 P4B585 U2E11 U2F13 U2F17 U2G02 U2G03 U2G11 U2G13 
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