Events

Recall of Device Recall Restep DVT System

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

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
    63692
  • Event Risk Class
    Class 2
  • Event Number
    Z-0840-2013
  • Event Initiated Date
    2012-08-30
  • Event Date Posted
    2013-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114588
  • 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
    Sleeve, limb, compressible - Product Code JOW
  • Reason
    Reports that the ac power adaptor may not operate due to wires coming loose in the unit.
  • Action
    Stryker Sustainability Solutions sent a Urgent Medical Device Removal Notification letter dated September 5, 2012, to all affected customers. The letter identified the product, problem and the action to be taken by the customer. The firm notified that affected AC Power Adaptors would be replaced with improved Adaptors. Any affected lots would be removed and shipped back to Stryker Sustainability Solutions for final disposition. Customers were instructed to fill out the attached Recall Effectiveness Form even if no affected product was found and fax to Stryker Sustainability Solutions at (480) 809-4957

Device

Device Recall Restep DVT System
  • Model / Serial
    108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in Arizona and New Jersey.
  • Product Description
    STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Manufacturer Address
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA