Events

Recall of Circular Staplers

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

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
    53694
  • Event Risk Class
    Class 2
  • Event Number
    Z-0393-2010
  • Event Initiated Date
    2009-09-23
  • Event Date Posted
    2009-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86348
  • 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
    Implantable staple. - Product Code GDW
  • Reason
    Lack of assurance that products were manufactured under gmps. this action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.
  • Action
    The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.

Device

Circular Staplers
  • Model / Serial
    all codes
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece.
  • Product Description
    Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Digital Loading Unit, product code CS25; Circular Stapler 29 mm Digital Loading Unit, product code CS29; Circular Stapler 33 mm Digital Loading Unit, product code CS33.
  • Manufacturer
    Surgical Devices/Covidien

Manufacturer

Surgical Devices/Covidien
  • Manufacturer Address
    Surgical Devices/Covidien, 60 Middletown Ave, North Haven CT 06473-3908
  • Source
    USFDA