Events

Recall of Device Recall ChordX Chordal Sizer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by On-X Life Technologies, Inc..

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
    75951
  • Event Risk Class
    Class 2
  • Event Number
    Z-1057-2017
  • Event Initiated Date
    2016-12-13
  • Event Date Posted
    2017-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151822
  • 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
    Nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replac - Product Code PAW
  • Reason
    Four issues were uncovered by the recalling firm's capa: 1) burrs were found to be present on left housing, right housing and barrel components, 2) loose plastic particulate was found within sealed primary packages, 3) loose hair was discovered within four sealed primary packages and 4) assembly error, wherein left and right housing components were acceptably press-fit together, was discovered within one sealed primary package. one of the left housing press-fit pins was not pressed into the associated hole of the right housing, resulting in a small gap in the housing assembly.
  • Action
    A letter was sent to the implanting surgerons notifyijng them of the recall and attemmpting retrieval.

Device

Device Recall ChordX Chordal Sizer
  • Model / Serial
    72-00-47420
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    CA, WA, NE, DE, OH, ME, TX
  • Product Description
    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
  • Manufacturer
    On-X Life Technologies, Inc.

Manufacturer

On-X Life Technologies, Inc.
  • Manufacturer Address
    On-X Life Technologies, Inc., 1300 E Anderson Ln Ste B, Austin TX 78752-1739
  • Source
    USFDA