Events

Recall of Device Recall M.U.S.T. Rod

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medacta Usa 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
    76034
  • Event Risk Class
    Class 2
  • Event Number
    Z-1023-2017
  • Event Initiated Date
    2016-12-07
  • Event Date Posted
    2017-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152015
  • 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
    Appliance, fixation, spinal interlaminal - Product Code KWP
  • Reason
    Damaged packaging, lack of sterility assurance.
  • Action
    The firm, Medacta International, immediately notified all customers by phone on 12/07/16 and further notified via email on 12/9/16. The firm also issued an "URGENT- Field Safety Notice" dated 7/12/2016 to all its customers. The notice described the product, problem and actions to be taken. The customers were instructed to return all units to Medacta International SA and forward the notice to all people and organizations potentially affected. If you have any questions contact Regulatory Affairs Manager at +41 (0) 91 696 60 60.

Device

Device Recall M.U.S.T. Rod
  • Model / Serial
    Lot #s 125212,144216, 148146
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
  • Product Description
    Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo || The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.
  • Manufacturer
    Medacta Usa Inc

Manufacturer

Medacta Usa Inc
  • Manufacturer Address
    Medacta Usa Inc, 3973 Delp St, Memphis TN 38118-6110
  • Manufacturer Parent Company (2017)
    Medacta Holding Sa
  • Source
    USFDA