Events

Recall of Device Recall Tornier Latitude Elbow Prosthesis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tornier, 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
    59399
  • Event Risk Class
    Class 2
  • Event Number
    Z-3082-2011
  • Event Initiated Date
    2011-06-23
  • Event Date Posted
    2011-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102625
  • 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
    Prosthesis, elbow, semi-constrained, cemented - Product Code JDB
  • Reason
    Tornier has discovered that some models of the tornier latitude elbow prosthesis (small and medium humeral stems) were manufactured with a humeral screw that may not function as designed.
  • Action
    Tornier, Inc. sent an "Urgent Product Correction" letter dated June 23, 2011. The letter was addressed to the doctors. The letter described the product and the problem. Doctors were insructed to monitor patients that have received the units for evidence of humeral screw loosening. For questions customers were instructed to contact the Customer Service Department at 1-888-494-7950.

Device

Device Recall Tornier Latitude Elbow Prosthesis
  • Model / Serial
    CC0810047
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including FL and MO
  • Product Description
    Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA. || The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using others techniques. The Tornier In. Latitude Elbow Prosthesis is intended for cemented use only.
  • Manufacturer
    Tornier, Inc

Manufacturer

Tornier, Inc
  • Manufacturer Address
    Tornier, Inc, 7701 France Ave S Ste 600, Edina MN 55435-3202
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA