Events

Recall of Musculoskeletal Transplant Foundation

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
    74263
  • Event Risk Class
    Class 2
  • Event Number
    Z-2004-2016
  • Event Initiated Date
    2016-04-21
  • Event Date Posted
    2016-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147014
  • 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
    Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
  • Reason
    Aft diverted tubes are being recalled due to a customer complaint involving one unit which had an unsealed tyvek pouch. the non-sterile foil pouch may introduce contamination into the sterile field.
  • Action
    Musculoskeletal Transplant Foundation (MTF) sent an Voluntary Field Action Notification Letter dated April 21, 2016, and via telephone to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were notified of the situation with the product and provided instructions on how to handle the product. Questions can be directed to Customer Service Customer at 1-800-433-6576.

Device

Musculoskeletal Transplant Foundation
  • Model / Serial
    Serial 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    nationwide
  • Product Description
    Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
  • Manufacturer
    Musculoskeletal Transplant Foundation, Inc.

Manufacturer

Musculoskeletal Transplant Foundation, Inc.