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-0959-04
  • 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=32945
  • 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# P2J505 P2J971 P2K1031 P2K813 P2L332 P2L603 P2L604 P2M227 P2M228 P2M235 P2M82 P3A1151 P3A323 P3A443 P3A908 P3B336 P3B607 P3C710 P3C802 P3D563 P3D944 P3E233 P3E294 P3G08 P3G09 P3G417 P3G621 P3G769 P3H288 P3H638 P3J41 P3J456 P3K05 P3K06 P3K07 P3K08 P3L1007 P3L1008 P3L11 P3L1129 P3L1130 P3L12 P3L243 P3L42 P3L425 P3L440 P3L441 P3M368 P3M369 P4A634 P4A881 U2H02 U2H08
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Auto SutureTA 30 Reloadable Stapler,Single Patient Use,3.5mm DST Series || Ref: TA3035S
  • Manufacturer
    United States Surgical

Manufacturer

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