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-0965-04
  • 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=33005
  • 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# P2H679 P2J642 P2K1113 P2K534 P2K66 P2L609 P2L610 P2L611 P2L649 P2M692 P3A650 P3C425 P3C800 P3E304 P3F686 P3G15 P3G414 P3J249 P3J250 P3J256 P3L1013 P3L1141 P3L242 P3L44 P3L462 P3L639 P4A547 P4A642 P4A890 P4B727 U2G21
  • 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, 3.5mm DST Series || Ref: TA9035S
  • Manufacturer
    United States Surgical

Manufacturer

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