Events

Recall of Device Recall InFast Ultra Transvaginal Bladder Neck Support System

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

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
    46833
  • Event Risk Class
    Class 2
  • Event Number
    Z-1235-2008
  • Event Initiated Date
    2008-01-28
  • Event Date Posted
    2008-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68313
  • 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
    Fastener, Fixation, Nondegradable, Soft Tissue - Product Code MBI
  • Reason
    Missing part: the units in two lots of in-fast ultra transvaginal bladder neck support system may contain only one bone screw, but should contain two as indicated on the labeling. two screws are required to complete the procedure. the missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available.
  • Action
    All customers received phone calls on 1/28/08 explaining the error and associated risks and were followed up with detailed letters. The letter "AMS Important Product Recall" dated 1/28/08 described the product and problem. Customers were advised to return the enclosed "Recall Acknowledgement Form" to AMS along with any affected product that they have in inventory.

Device

Device Recall InFast Ultra Transvaginal Bladder Neck Support System
  • Model / Serial
    Lot Numbers: 527059 and 527061.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.
  • Manufacturer
    American Medical Systems

Manufacturer

American Medical Systems
  • Manufacturer Address
    American Medical Systems, 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA