Events

Recall of Device Recall Asnis III Csnnulated Screw 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
    65891
  • Event Risk Class
    Class 2
  • Event Number
    Z-2099-2013
  • Event Initiated Date
    2013-07-08
  • Event Date Posted
    2013-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120729
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    Stryker received a report that the length of the cannulated screw asnis iii, article # 604640 lot r11482, was incorrect.
  • Action
    Stryker sent an Urgent Medical Device Removal letter dated July 8, 2013 via Fed Ex to all affected customers. The letter identified the affected product, product issues, potential hazards, risk mitigation and actions to be taken. Customers were instructed to return all affected products available to Stryer Osteosynthesis or contact Stryer customer service and complete and sign the enclosed Business Reply Form and fax a copy to: 1-865-251-3635. Questions can be directed to Stryker at 201-972-2100.

Device

Device Recall Asnis III Csnnulated Screw System
  • Model / Serial
    Catalog # 604640, Lot Code R11428 21 units  Catalog # 604642S, Lot Code R09071 1 unit
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution in the states of: FL. OH, TX, & VA
  • Product Description
    Stryker || 1) Asnis III Cannulated Screw REF 604640 || 4.0x40mm TL 13.5mm || 2) Asnis III Cannulated Screw REF 604642S || 4.0x42mm TL 14mm, sterile || Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA