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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-0963-04
Recall Event ID 28998
510(K)Number K013860  
Product Classification Staple, Implantable - Product Code GDW
Product Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 3.5mm DST Series
Ref: TA6035S
Code Information LOT# P2G906 P2G907 P2G908 P2J239 P2J239A P2J451 P2J559 P2K1053 P2K1054 P2K1055 P2K334 P2K617 P2L129 P2L130 P2L131 P2L651 P2L652 P2L653 P2L654 P2M194 P2M195 P3A119 P3A120 P3A121 P3A415 P3A416 P3A417 P3A646 P3A910 P3B33 P3B34 P3C627 P3C738 P3D249 P3D251 P3D252 P3D571 P3D572 P3D582 P3D583 P3F464 P3F465 P3F466 P3F467 P3F685 P3G195 P3G196 P3G197 P3G766 P3G871 P3H248 P3H250 P3J460 P3J48 P3J49 P3J50 P3J719 P3K22 P3K23 P3K24 P3K25 P3K358 P3K359 P3L1000 P3L1001 P3L1002 P3L1003 P3L1144 P3L1145 P3L1146 P3L1148 P3L225 P3L226 P3L227 P3L228 P3L452 P3L453 P3L454 P3L455 P3L456 P3L633 P3L634 P3L635 P3L636 P3L637 P3L999 P3M551 P4A130 P4A133 P4A135 P4A560 P4A641 P4A888 P4B243 P4B267 U2F03 U2F07 U2F12 U2F27 
Recalling Firm/
Manufacturer		 United States Surgical
195 Mcdermott Rd
North Haven CT 06473-3665
For Additional Information Contact Garry Raymond
203-492-8165
Manufacturer Reason
for Recall		 Stapler may clamp without the staples being fired into the tissue
FDA Determined
Cause 2		 Other
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
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