Events

Recall of Accolade II 127 Neck Angle Hip Stem

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
    66761
  • Event Risk Class
    Class 2
  • Event Number
    Z-0467-2014
  • Event Initiated Date
    2013-10-25
  • Event Date Posted
    2013-12-07
  • 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=123306
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Reason
    Stryker received a report from the field indicating that an accolade ii hip stem size #3 was identified in packaging with an accolade ii hip stem size #5.
  • Action
    Stryker sent an e-mail to their domestic locations on 10/11/2013. Notification letters and product accountability forms were sent via Fed Ex on 10/25/2013 with return receipt to branches/agencies and hospital risk management, chief of orthopaedics and surgeons.

Device

Accolade II 127 Neck Angle Hip Stem
  • Model / Serial
    510K K120578  Accolade II I27 Neck Angle Hip Stem, Size # 3 Catalog No.# 6721-0330 Lot Code #44416307  Accolade II 127 Neck Angle Hip Stem, Size #5 Catalog No. # 6721-0535 Lot Code 44564405
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states: AL, GA, IL, and WA.
  • Product Description
    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 || 2) Accolade II 127 Neck Angle Hip Stem, Size #5 || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 USA || Telephone # +1 201-831-5000 || Stryker France || ZAC Satolas Green Pusignan || Av de Satolas Green || 69881 MEYZIEU Cedex France || Intended for cementless application in total or hemiarthroplasty procedures.
  • 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