Events

Recall of Device Recall AXSOS PLUS LOCKING PLATE SYSTEM

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

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
    50850
  • Event Risk Class
    Class 2
  • Event Number
    Z-1063-2009
  • Event Initiated Date
    2008-11-24
  • Event Date Posted
    2009-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77489
  • 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
    AxSOS Torque Limiting Screwdriver - Product Code HRS
  • Reason
    Potential breakage: stryker orthopaedics became aware that there is the potential for the tip of the axsos screwdriver and the axsos torque limiter to break.
  • Action
    "Urgent Product Recall" letters were sent to Stryker Orthopaedics Branches/Agencies, Chief of Orthopaedics, Hospital Risk Management and Surgeons on November 24, 2008 via Federal Express. The letters described the issue and provided the following instructions: 1. Examine your inventory and determine if you have any of the affected product, 2. Remove and quarantine affected product from your inventory, 3. Complete the attached Product Recall Acknowledgement Form (and fax to Stryker Orthopaedics at 201-831-6069), and 4. Return the affected product to your Stryker Orthopaedics Sales representative. Direct questions to your Stryker Orthopaedics Sales Representative or call Stryker Orthopaedics at 201-831-5000.

Device

Device Recall AXSOS PLUS LOCKING PLATE SYSTEM
  • Model / Serial
    All lot codes.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile. || Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ. || The torque limiter is used for final tightening locking screws to the plate in order to avoid over tightening of the locking screws.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA