• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall United States Surgical

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall United States Surgicalsee related information
Date Initiated by FirmMay 05, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 15, 2006
Recall NumberZ-0966-04
Recall Event ID 28998
510(K)NumberK013860 
Product Classification Staple, Implantable - Product Code GDW
ProductAuto SutureTA 90 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA9048S
Code Information LOT# P2H677 P2H678 P2J787 P2J788 P2L645 P2L646 P2L650 P2M226 P2M693 P3A652 P3B308 P3B613 P3C426 P3C432 P3C819 P3D953 P3E649 P3F116 P3F841 P3G16 P3G17 P3H281 P3H282 P3H447 P3H448 P3K27 P3K362 P3L1014 P3L1015 P3L1142 P3L231 P3L232 P3L45 P3L464 P3L465 P3L466 P3L731 P4A546 P4A643 P4A891 U2G15 
Recalling Firm/
Manufacturer
United States Surgical
195 Mcdermott Rd
North Haven CT 06473-3665
For Additional Information ContactGarry Raymond
203-492-8165
Manufacturer Reason
for Recall
Stapler may clamp without the staples being fired into the tissue
FDA Determined
Cause 2
Other
ActionUnited States Surgical notiied direct accounts by letter dated 5/5/04. Accounts are requested to inventory and quarantine product for return to USS.
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GDW
-
-