Events

Recall of Stryker AVS AL Spacer Trial Inserter

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

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
    50774
  • Event Risk Class
    Class 2
  • Event Number
    Z-0936-2009
  • Event Initiated Date
    2006-09-08
  • Event Date Posted
    2009-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77160
  • 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
    Manual Surgical Instrument for General Use - Product Code MDM
  • Reason
    Design flaw: issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.
  • Action
    Market Withdrawal letters were sent out on September 8, 2006 to all branches who received device. The letter asked customers to examine their inventory and hospital consignment locations to identify the product. Also, customers needed to reconcile all products on the attached Product Accountability Form and fax a copy back. The affected products were to be retrieved and returned using the "Product Returns Procedure".

Device

Stryker AVS AL Spacer Trial Inserter
  • Model / Serial
    Lot Codes: 056398 and 056399.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including state of NJ.
  • Product Description
    Stryker AVS AL Spacer Trial Inserter; || Non Sterile. Catalog number: 48329800 || Manufactured by Stryker Spine SAS, Cestas, France. || Distributed in USA by Osteonics Corp., Mahwah, NJ.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Manufacturer Address
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA