Events

Recall of Device Recall AEQUALIS HUMERAL NAIL DRILL BIT

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
    79907
  • Event Risk Class
    Class 2
  • Event Number
    Z-1757-2018
  • Event Initiated Date
    2018-03-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163906
  • 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
    Bit, drill - Product Code HTW
  • Reason
    Drill bit tips without new bargergard tip protector may puncture through sterile packaging.
  • Action
    The firm contacted its distributors by email on 26-March-2018, and a written letter sent 27-March-2018 via FedEx. The Medical Facility was contacted with a written letter sent 28-March-2018 via FedEx.. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the attached Acknowledgement to Wright Medical via email to FieldAction@wright.com. For questions call 952-683-7482.

Device

Device Recall AEQUALIS HUMERAL NAIL DRILL BIT
  • Model / Serial
    Lot numbers:  BA0112130 BA0114126 BA0114174 BA0114279 BA0114344 BA0115022 BA0115071 BA0115203 BA0117059 BA0117083 BA0117100 BA0117145 BA0177206 BA0215015 BA0215022 BA0215203 BA0312130 BA0315203 BA0412130 BA0415203 BA0515203 BA0615203
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 || Product Usage: || The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
  • 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