Events

Recall of Device Recall Direct Supply aluminum crutch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Depot 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
    73918
  • Event Risk Class
    Class 2
  • Event Number
    Z-2106-2016
  • Event Initiated Date
    2016-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145418
  • 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
    Tips and pads, cane, crutch and walker - Product Code INP
  • Reason
    Tip crutch failure involving the bottom of the metal portion which comes in contact with ground.
  • Action
    On February 17, 2016, drive DeVilbiss Healthcare issued a preliminary notice their customers informing them of the situation via courier service. Secondly, On February 25, 2016, drive DeVilbiss Healthcare distributed another notice informing customers that the potential issue was confirmed to a limited number of lots. Customers were advised to quarantine all products in inventory as replacement products will be provided. The company notified customers that they will commence shipping orders for the product on Monday, February 29, 2016. Customers were also advised that a substantial inventory of replacement crutch tips for distribution will begin on or about March 7, 2016. On March 11, 2016, drive DeVilbiss distributed a third notice to their customers via courier service advising them of customer reimbursement for time and labor costs associated with this action. Drive Devilbiss Healthcare will reimburse based on the total number of tips requested to be shipped. Lastly, on May 12, 2016, drive DeVilbiss distributed a fourth Urgent Medical Device notice and response form to their customers via email. drive DeVilbiss advised customers to: 1) quarantine any stock that has not been inspected already and compare serial numbers of stocks to list provided, 2) any product received after 3/7/16 has been fully inspected and has an approved crutch tip that is free of defect, 3) if products were further distributed, contact those customers who received product between 7/2015 to 12/2015 and determine if items are still being used, 4) If the customer is still using this item, contact your sales representative so the return and replacement of this product can be processed and 5) complete and return the response form vial email. Customers with questions can contact by telephone 516-998-4600 ext. 4422.

Device

Device Recall Direct Supply aluminum crutch
  • Model / Serial
    Item #: DS 10400
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Direct Supply aluminum crutch, adult, 1 pair per case || Aid the user in walking while relieving weight from one foot or leg.
  • Manufacturer
    Medical Depot Inc.

Manufacturer

Medical Depot Inc.
  • Manufacturer Address
    Medical Depot Inc., 99 Seaview Blvd Fl 2, Port Washington NY 11050-4606
  • Manufacturer Parent Company (2017)
    Medical Depot Inc.
  • Source
    USFDA