Events

Recall of Device Recall Aequalis Humeral Nail Targeting Jig

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
    71605
  • Event Risk Class
    Class 2
  • Event Number
    Z-2315-2015
  • Event Initiated Date
    2015-06-25
  • Event Date Posted
    2015-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138353
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    Recall for the aequalis im nail instrumentation set (tray number 9020000) due to several reports that the mast of the targeting jig (part number 9020060) is separating from the jig boom. separation will impact alignment and can affect the ability to fixate aequalis im nail screws.
  • Action
    Consignees were sent on 6/25/2015 a Tornier "Urgent Medical Device Recall" letter dated June 24, 2015. The letter described the problem and the product affected by the recall. The letter provided information on jig inspection and referred consignee to the attached "Perfect Circles' surgical technique that should be used when separation is observed. Requested consignees to complete and return the questionnaire to FieldAction@tornier.com. For questions they can contact Customer Service Department at 1(888)494-7950.

Device

Device Recall Aequalis Humeral Nail Targeting Jig
  • Model / Serial
    Lots: DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE.
  • Product Description
    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. 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