Events

Recall of Device Recall GMD UNIVERSAL URINARY INCONTINENCE 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
    56670
  • Event Risk Class
    Class 2
  • Event Number
    Z-1390-2011
  • Event Initiated Date
    2011-02-14
  • Event Date Posted
    2011-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94212
  • 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, polymeric - Product Code FTL
  • Reason
    Protective sheath sticks to itself and sleeve breakage has resulted in complaints and mdrs.
  • Action
    The firm, GMD, issued an "URGENT MEDICAL DEVICE RECALL" letter dated February 14, 2011 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed not to use any GMD Model 1010 Universal Slings remaining in their inventory; return any Model 1010 slings in their possession to the Distributors or GMD; notify their customers to whom they shipped Model 1010s of this voluntary recall and request them to return any Model 1010 slings in their possession to them; and return all Model 1010 inventories to GMD using the attached Recalled Model 1010 Return Form. Note: Full credit in the amount of the returned products purchase price will be issued for all sterile, unexpired product returned to GMD. Contact the GMD Product Performance Senior Manager, at phone: (253) 853 3512 or email: 1010recall@gmd-us.com, if you have any questions/issues related to this recall.

Device

Device Recall GMD UNIVERSAL URINARY INCONTINENCE SLING
  • Model / Serial
    All model number 1010 Universal Sleeved Slings. It cannot be determined whether each Sling is identified by an individual serial number.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Argentina, Brazil, Canada, South Africa, and Scandinavia.
  • Product Description
    The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. || The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable universal low density polyethylene sleeve at each end of attachment of the sling to GMD's single use or reusable trocars. The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out, bottom-up approaches and a sleeve end trocar insertion point is for outside-in, top-down approaches. The design allows the physician to utilize the device for placement of a polypropylene mesh at the urethra or bladder neck.
  • Manufacturer
    Generic Medical Devices

Manufacturer

Generic Medical Devices
  • Manufacturer Address
    Generic Medical Devices, 5727 Baker Way Nw Ste 201, Gig Harbor WA 98332-5811
  • Manufacturer Parent Company (2017)
    Generic Medical Devices Inc.
  • Source
    USFDA