Events

Recall of Device Recall Digitex 20 Polydioxanone (PDO) suture

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coloplast Manufacturing US, LLC.

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
    65314
  • Event Risk Class
    Class 2
  • Event Number
    Z-1486-2013
  • Event Initiated Date
    2013-05-13
  • Event Date Posted
    2013-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118540
  • 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
    Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • Reason
    Coloplast is conducting a recall on three lots of digitex absorbable polydiaxanone suture, size 2-0 because it is mislabeled with a three year expiration date.
  • Action
    The firm, Coloplast, sent a letter dated May 8, 2013 to its customers. The letter described the problem, the product and actions to be taken. The customers will be contacted by Coloplast Customer Service with instructions for the handling and return of any unused product. If you have any additional questions, the dedicated Customer Service number regarding this effort is 800-258-3476.

Device

Device Recall Digitex 20 Polydioxanone (PDO) suture
  • Model / Serial
    Lots 3390331, 3390339, 3390490.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to: KY, MI, OH, PR, TX, and VA.
  • Product Description
    Digitex Absorbable Polydiaxanone Suture, Size 2-0. || Catalog Number / Code of product: 52031, 5203101400. || The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.
  • Manufacturer
    Coloplast Manufacturing US, LLC

Manufacturer

Coloplast Manufacturing US, LLC
  • Manufacturer Address
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3431
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Source
    USFDA