Events

Recall of Hydrocision

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hydrocision, 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
    36240
  • Event Risk Class
    Class 2
  • Event Number
    Z-0124-2007
  • Event Initiated Date
    2006-09-07
  • Event Date Posted
    2006-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48240
  • 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
    tissue ablating handpiece - Product Code HRX
  • Reason
    Distal tip may become detached from the device.
  • Action
    Hydrocision contacted customers and sales reps by email on 9/6/06 advising to users to discontinue use and return recalled units.

Device

Hydrocision
  • Model / Serial
    Lot Number 75GF2530
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. || Catalog Number 58663
  • Manufacturer
    Hydrocision, Inc.

Manufacturer

Hydrocision, Inc.
  • Manufacturer Address
    Hydrocision, Inc., 22 Linnell Cir Ste 102, Billerica MA 01821-3901
  • Source
    USFDA