Events

Recall of Device Recall Total Hip Joint Replacement

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
    59968
  • Event Risk Class
    Class 2
  • Event Number
    Z-0075-2012
  • Event Initiated Date
    2011-07-14
  • Event Date Posted
    2011-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104199
  • 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
    Stryker orthopaedics has become aware that a size 3 accolade stem was in a box labeled as a size 5 accolade stem.
  • Action
    Stryker Orthopaedics sent an "URGENT: PRODUCT RECALL" letter dated July 14, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an attached Product Recall Acknowledgment Form via fax to 201-831-6069. Additionally, information is provided for customers to return the affected products. Please contact the Divisional Regulatory Compliance Manager at 201-972-2100 for questions regarding this notice.

Device

Device Recall Total Hip Joint Replacement
  • Model / Serial
    K994366 6021-0335 6021-0537  Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3; Catalog #6021-0335 Lot Code 35427003;  Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5; Catalog #6021-0537 Lot Code 35202601
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Total Hip Joint Replacement || Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 || Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5 || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 || A subsidiary of Stryker Corp. || Stryker France || ZAC Satolos Green Pusignan || Av de Staolas Green 69881 Metziae || Cedex France || The TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem are intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. These stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5 40 BG taper.
  • 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