Events

Recall of Device Recall Musculoskeletal Transplant Foundation DBX Demineralized Bone Matrix Mix

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
    70739
  • Event Risk Class
    Class 2
  • Event Number
    Z-1455-2015
  • Event Initiated Date
    2014-12-04
  • Event Date Posted
    2015-04-17
  • 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=134582
  • 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, calcium compound - Product Code MQV
  • Reason
    The seal on the dbx mix outer petg/aclar tray with foil lid packaging for lot identified above may not be fully intact.
  • Action
    MTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter.

Device

Device Recall Musculoskeletal Transplant Foundation DBX Demineralized Bone Matrix Mix
  • Model / Serial
    064130067910690008; 064130067910690009; 064130067910690004; 064130067910690023; 064130067910690024 064130067910690005; 064130067910690015; 064130067910690016; 064130067910690018; 064130067910690020; 064130067910690007; 064130067910690013; 064130067910690028; 064130067910690029; 064130067910690030; 064130067910690010; 064130067910690006; 064130067910690011; 064130067910690012; 064130067910690019; 064130067910690021; 064130067910690014; 064130067910690017; 064130067910690001; 064130067910690022
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.
  • Product Description
    DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
  • Manufacturer
    Musculoskeletal Transplant Foundation, Inc.

Manufacturer

Musculoskeletal Transplant Foundation, Inc.