Events

Recall of Device Recall SurgAssist System Circular Stapler DLU 33mm

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

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
    27764
  • Event Risk Class
    Class 2
  • Event Number
    Z-0253-04
  • Event Initiated Date
    2003-11-20
  • Event Date Posted
    2003-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30491
  • 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
    Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp - Product Code GWD
  • Reason
    Improper staple formation or anvil jam.
  • Action
    On 11/20/03, the recalling firm sent recall notices via overnight carrier to all customers who have been shippped and/or sold the product. The recall notice requested the return of the devices.

Device

Device Recall SurgAssist System Circular Stapler DLU 33mm
  • Model / Serial
    Product Code CS33, Lot numbers LC-000134, LC-000135, LC-000136, LC-000140, and LC-000144.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities and sales representatives nationwide. The product was also shipped to distributors in the United Kingdom, France, Scotland, Belgium, Germany, Israel, Italy, Japan, Spain, Portugal, and Sweden.
  • Product Description
    SurgAssist System Circular Stapler DLU 33mm
  • Manufacturer
    Power Medical Interventions

Manufacturer

Power Medical Interventions
  • Manufacturer Address
    Power Medical Interventions, 110 Union Square Dr, New Hope PA 18938-1365
  • Source
    USFDA