Events

Recall of Device Recall AmTryke

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Amtryke LLC.

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
    70888
  • Event Risk Class
    Class 2
  • Event Number
    Z-1520-2015
  • Event Initiated Date
    2015-03-27
  • Event Date Posted
    2015-04-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135405
  • 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
    Exerciser, non-measuring - Product Code ION
  • Reason
    Product is being recalled due to complaints of cracked frames.
  • Action
    Consignees were notified via letter on 03/27/2015.

Device

Device Recall AmTryke
  • Model / Serial
    Model: 1424, System number 50-HC-1424, Batch number 2-1301 and GM-0314.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US nationwide distribution to AL, CA, FL, HI, IL, KY, KS, LA, MI, NY, OK, OR, PA, SC, TX, VA, VT and WV.
  • Product Description
    AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle.
  • Manufacturer
    Amtryke LLC

Manufacturer

Amtryke LLC
  • Manufacturer Address
    Amtryke LLC, 4285 Regency Dr, Greensboro NC 27410-8101
  • Source
    USFDA