Events

Recall of Device Recall ACCOLADE TMZF PLUS HA 127 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-1366-2009
  • Event Initiated Date
    2009-01-06
  • Event Date Posted
    2009-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78785
  • 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

Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
  • Model / Serial
    6021-0435 ACCOLADE (127 DEG) SIZE 4 24884802 6021-0435 ACCOLADE (127 DEG) SIZE 4 24918803 6021-0435 ACCOLADE (127 DEG) SIZE 4 25045801 6021-0435 ACCOLADE (127 DEG) SIZE 4 25045802 6021-0435 ACCOLADE (127 DEG) SIZE 4 25069801 6021-0435 ACCOLADE (127 DEG) SIZE 4 25080502 6021-0435 ACCOLADE (127 DEG) SIZE 4 25094901 6021-0435 ACCOLADE (127 DEG) SIZE 4 25108901 6021-0435 ACCOLADE (127 DEG) SIZE 4 25138302 6021-0435 ACCOLADE (127 DEG) SIZE 4 25179401 6021-0435 ACCOLADE (127 DEG) SIZE 4 25211501 6021-0435 ACCOLADE (127 DEG) SIZE 4 25231401 6021-0435 ACCOLADE (127 DEG) SIZE 4 25255902 6021-0435 ACCOLADE (127 DEG) SIZE 4 25311401 6021-0435 ACCOLADE (127 DEG) SIZE 4 25311402 6021-0435 ACCOLADE (127 DEG) SIZE 4 25337801 6021-0435 ACCOLADE (127 DEG) SIZE 4 25400803 and 6021-0435 ACCOLADE (127 DEG) SIZE 4 25515602.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; || V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 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
    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