Recall of Device Recall ACCOLADE TMZF HA 132 DEGREE SIZE 0 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
    50901
  • Event Risk Class
    Class 2
  • Event Number
    Z-1357-2009
  • Event Initiated Date
    2009-01-06
  • Event Date Posted
    2009-07-22
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-06-25
  • Event Source
    USFDA
  • Event Source URL
  • 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, calicum-phosphate - Product Code MEH
  • Reason
    Product deviation : specific lots of sprayed ha hip stems did not meet stryker's internal material specification for tensile bond strength and crystallinity.
  • Action
    An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.

Device

  • Model / Serial
    6020-0335 ACCOLADE 132 SIZE 3 24972401 6020-0335 ACCOLADE 132 SIZE 3 25004402 6020-0335 ACCOLADE 132 SIZE 3 25045302 6020-0335 ACCOLADE 132 SIZE 3 25045303 6020-0335 ACCOLADE 132 SIZE 3 25107804 6020-0335 ACCOLADE 132 SIZE 3 25178601 6020-0335 ACCOLADE 132 SIZE 3 25230801 6020-0335 ACCOLADE 132 SIZE 3 25230802 6020-0335 ACCOLADE 132 SIZE 3 25245502 6020-0335 ACCOLADE 132 SIZE 3 25245503 6020-0335 ACCOLADE 132 SIZE 3 25255101 6020-0335 ACCOLADE 132 SIZE 3 25274002 6020-0335 ACCOLADE 132 SIZE 3 25348901 and 6020-0335 ACCOLADE 132 SIZE 3 25386101.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
  • Manufacturer

Manufacturer

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