Events

Recall of Device Recall Musculoskeletal Transplant Foundation Allofix Insertion Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Musculoskeletal Transplant Foundation, 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
    71559
  • Event Risk Class
    Class 2
  • Event Number
    Z-2075-2015
  • Event Initiated Date
    2015-05-27
  • Event Date Posted
    2015-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138188
  • 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
    Brace, drill - Product Code HXY
  • Reason
    Musculoskeletal transplant foundation is recalling a certain lot of allofix insertion kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
  • Action
    Musculoskeletal Transplant Foundation notified their affected customers of this recall by sending them a Voluntary Recall Notification Letter dated May 27, 2015 or via telephone. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 1-800-433-6576.

Device

Device Recall Musculoskeletal Transplant Foundation Allofix Insertion Kit
  • Model / Serial
    Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.
  • Product Description
    Allofix Insertion Kit, 2.0 mm, Single Drill, || Product Usage: || MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
  • Manufacturer
    Musculoskeletal Transplant Foundation, Inc.

Manufacturer

Musculoskeletal Transplant Foundation, Inc.