Events

Recall of Device Recall suburethral sling

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

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
    52546
  • Event Risk Class
    Class 3
  • Event Number
    Z-0268-2010
  • Event Initiated Date
    2009-06-18
  • Event Date Posted
    2009-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83271
  • 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
    Surgical mesh - Product Code FTL
  • Reason
    Product that is approved only for use outside the u.S. was shipped to two customers in the u.S.
  • Action
    On June 17, 2009 the recalling firm called the consignees and arranged for the unused product to be returned. On July 13, 2009 the firm sent a notification letter to the consignee that had implanted 1 of the devices.

Device

Device Recall suburethral sling
  • Model / Serial
    Lot number 21664
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA - NJ, and PA
  • Product Description
    GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. || Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.
  • Manufacturer
    Generic Medical Devices

Manufacturer

Generic Medical Devices
  • Manufacturer Address
    Generic Medical Devices, 5727 Baker Way NW, Suite 201, Gig Harbor WA 98332
  • Manufacturer Parent Company (2017)
    Generic Medical Devices Inc.
  • Source
    USFDA