Events

Recall of Rostorelle L, Polypropylene Mesh

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
    64943
  • Event Risk Class
    Class 2
  • Event Number
    Z-1341-2013
  • Event Initiated Date
    2013-04-12
  • Event Date Posted
    2013-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117480
  • 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
    Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally - Product Code OTO
  • Reason
    Coloplast is recalling one lot of restorelle l prosthesis because it is mislabeled. the incorrect instructions for use (ifu) pamphlet is included in the packaging.
  • Action
    Coloplast sent a letter to dated April 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included an attachment with the correct IFU to replace the incorrect IFU. Customers with questions were instructed to call Customer Service at 800-258-3476. For questions regarding this recall call 612-302-4992.

Device

Rostorelle L, Polypropylene Mesh
  • Model / Serial
    3483171
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
  • Product Description
    Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
  • 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