Events

Recall of Device Recall Dekompressor Percutaneous Discectomy Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

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
    66456
  • Event Risk Class
    Class 2
  • Event Number
    Z-0127-2014
  • Event Initiated Date
    2013-11-04
  • Event Date Posted
    2013-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122425
  • 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
    Arthroscope - Product Code HRX
  • Reason
    Stryker has identified a potential for the auger and/or cannula to fracture when the dekompressor is used contrary to the warnings in the instructions for use (ifu). specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. this could result in the need for additional medical intervention to remove the broken piece, pain or loss of m.
  • Action
    On 11/4/13, an URGENT MEDICAL DEVICE Recall Notification was sent to all domestic consignees via mail and foreign by email. An advisory was sent to every physician that uses any of the products listed. Every physician that uses any of these products must print their name and sign below which means you acknowledge that youve received a copy of the attached advisory and that you understand the information regarding the proper usage of the Decompressor. Once the form has been signed by all physicians, the form must be completed and signed by the recall coordinator. Please fax to 866-521-2762 or email to kara.spath@stryker.com.

Device

Device Recall Dekompressor Percutaneous Discectomy Probe
  • Model / Serial
    Part Number(s) 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.
  • Product Description
    Dekompressor Percutaneous Discectomy Probe. || The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA