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-0966-04
  • 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=33006
  • 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# 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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 4.8mm DST Series || Ref: TA9048S
  • Manufacturer
    United States Surgical

Manufacturer

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