Events

Recall of Salto Talaris Tibial Guide

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
    71913
  • Event Risk Class
    Class 2
  • Event Number
    Z-2465-2015
  • Event Initiated Date
    2015-08-06
  • Event Date Posted
    2015-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139327
  • 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, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
  • Reason
    Tornier has initiated a voluntary recall for the salto talaris tibial guide (part number mju333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the salto talaris talar pin setting guide. this issue will cause the impossibility the time of putting the talar pin in the guide.
  • Action
    Distributors were sent on 8/6/2015 a Tornier "Urgent - Medical Device Recall" letter, dated August 5, 2015. The letter described the problem and the product involved in the recall. Consignees were advised to review their inventory and the inventory of all reps within their area for the recalled device. The letter requested that consignees complete and return the questionnaire to FieldAction@tornier.com. A Tornier representative will organize the collection and replacement of the devices. For questions they can contact Customer Service Department at 1 (888) 494-7950.

Device

Salto Talaris Tibial Guide
  • Model / Serial
    Lot #14F005
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to CA, ME, NC, PA, and TX.
  • Product Description
    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. || Orthopedic Manual Surgical Instrument
  • Manufacturer
    Tornier, Inc

Manufacturer

Tornier, Inc
  • Manufacturer Address
    Tornier, Inc, 10801 Nesbitt Ave S, Bloomington MN 55437-3109
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA