Events

Recall of Restoration HA Reduced Neck

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
    61338
  • Event Risk Class
    Class 2
  • Event Number
    Z-1677-2012
  • Event Initiated Date
    2011-10-27
  • Event Date Posted
    2012-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107822
  • 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, uncemented, metal/polymer, non-porous, calcium-phosphate - Product Code MEH
  • Reason
    An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.
  • Action
    Stryker sent an "URGENT PRODUCT RECALL" letter dated October 27, 2011 and October 28, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs the customers to return the product to the firm. An Acknowledgement Form was included for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.

Device

Restoration HA Reduced Neck
  • Model / Serial
    510(K) #K951671 Catalog #: S-2653-0812-L Affected Lot Codes 45041401 49051101 50024801 21578001 26464501A 49051101A 26464501C 97161201 54123101A 45041401C 18826701 49051101C 49760101A 49051101D 21473201 49051101E 54123101C 54008001C 50024801C 50024801D 97161201A 49760101C 50024801E 21473201A RK8MKE RK9MKE T7DMKE MHLL7Y MHM0DA MHJRE8-R
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution and the country of Canada.
  • Product Description
    Restoration HA Reduced Neck 255 mm Long Stem || Manufactured by Stryker Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430. || The Restoration HA cementless Hip System is designed to address the problems of revision surgery where extensive fixation both distally and proximally is required for support of the prosthesis. A comprehensive size range mates a variety of proximal cross sections and lengths with 10 distal cylindrical diameters to provide for patient matched sizing in revision circumstances. The stem design incorporates a physiologic 127 degree neck stem angle, neck length ranges and a C-Taper head to provide the surgeon with the ability to restore near anatomic head position for proper leg length and biomechanical function. Restoration HA femoral component accepts C-Taper heads, 22mm, 26mm, 28mm, and 32mm with a negative 5mm to positive 10mm offsets.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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