Events

Recall of Device Recall United States Surgical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by United States Surgical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28998
  • Event Risk Class
    Class 2
  • Event Number
    Z-0963-04
  • Event Initiated Date
    2004-05-05
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33003
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Staple, Implantable - Product Code GDW
  • Reason
    Stapler may clamp without the staples being fired into the tissue.
  • 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.

Device

Device Recall United States Surgical
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 3.5mm DST Series || Ref: TA6035S
  • Manufacturer
    United States Surgical

Manufacturer

United States Surgical
  • Manufacturer Address
    United States Surgical, 195 Mcdermott Rd, North Haven CT 06473-3665
  • Source
    USFDA