Events

Recall of Device Recall Matrix MAX 3

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Skf 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
    44962
  • Event Risk Class
    Class 2
  • Event Number
    Z-0217-2008
  • Event Initiated Date
    2007-07-24
  • Event Date Posted
    2007-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64653
  • 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
  • Reason
    Sudden failure of the actuator during lifting operation.
  • Action
    On or about 7/24/07, the firm sent an Important Safety Information letter and instructions to all known OEMs who purchase and sell SKF actuators for use in patient lifts. The letter reiterated and emphasized the importance of proper handling and maintenance for the actuator. The firm enclosed with this correspondence a proposed letter that the OEMs were asked to send to their customers, including the safety instructions and a new warning label. The firm also is making available for OEMs, dealers and their customers new warning labels to place on all actuators in service. The root cause of the problem is still under investigation by the recalling firm and additional instruction may follow later

Device

Device Recall Matrix MAX 3
  • Model / Serial
    Serial number 3072047
  • Distribution
    Worldwide Distribution-USA and Canada
  • Product Description
    Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403
  • Manufacturer
    Skf USA Inc

Manufacturer

Skf USA Inc
  • Manufacturer Address
    Skf USA Inc, 1111 Adams Ave, Norristown PA 19403-2403
  • Source
    USFDA