Events

Recall of Device Recall AC wall adapter for use with battery powered upper limb prosthesis.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Motion Control, 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
    32060
  • Event Risk Class
    Class 2
  • Event Number
    Z-0959-05
  • Event Initiated Date
    2005-02-01
  • Event Date Posted
    2005-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39058
  • 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
    Hand, External Limb Component, Powered - Product Code IQZ
  • Reason
    Incorrect ac wall adapter was distributed with prostheses. incorrect use of adapters could damage the battery and cause a potential fire hazard.
  • Action
    Consignees were notified by phone and letter on 2/3/2005.

Device

Device Recall AC wall adapter for use with battery powered upper limb prosthesis.
  • Model / Serial
    Part number PD1880 PL6A
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, DC, FL, NJ, OH, PA, SC, TN, TX, and Puerto Rico. No military, government or foreign distribution.
  • Product Description
    Spectre brand AC wall adapter to be used with ProControl 2 or ProHand battery powered upper limb prosthesis.
  • Manufacturer
    Motion Control, Inc.

Manufacturer

Motion Control, Inc.
  • Manufacturer Address
    Motion Control, Inc., 2401 S 1070 W Ste B, Salt Lake City UT 84119
  • Source
    USFDA