Events

Recall of Device Recall Gelzone Shoulder Sleeve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Implantech Associates 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
    67446
  • Event Risk Class
    Class 2
  • Event Number
    Z-1063-2014
  • Event Initiated Date
    2014-01-29
  • Event Date Posted
    2014-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125465
  • 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
    Apparatus, traction, non-powered - Product Code HST
  • Reason
    Implantech initiated the voluntary recall of gelzone shoulder sleever, slv-634, lot number 852766 because it may not satisfy customer requirements for the robustness of the velcro closure.
  • Action
    Implantech sent a Recall Notification letters dated January 29, 2014 via mail and fax to the affected customers. The recall notification letter informed customers of the voluntary recall, product description with code information, reason for recall, contact information, and actions to be taken. The letter also contains a response section to be completed and returned via fax. For questions call 1-800-733-0833 x235.

Device

Device Recall Gelzone Shoulder Sleeve
  • Model / Serial
    Catalog Number SLV634, Lot Number 852766.
  • Product Classification
    Neurological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.
  • Product Description
    Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. || Product Usage: || To be used where limb support and/or elevation is considered necessary.
  • Manufacturer
    Implantech Associates Inc

Manufacturer

Implantech Associates Inc
  • Manufacturer Address
    Implantech Associates Inc, 6025 Nicolle St Ste A, Ventura CA 93003-7602
  • Manufacturer Parent Company (2017)
    Implantech Associates Inc
  • Source
    USFDA