Events

Recall of Device Recall Stryker Orthopaedics

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
    71754
  • Event Risk Class
    Class 2
  • Event Number
    Z-2810-2015
  • Event Initiated Date
    2015-06-25
  • Event Date Posted
    2015-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138949
  • 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, porous uncemented - Product Code LPH
  • Reason
    It was discovered that item 623-10-36i lot 3y0khp, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. however the parts were inadvertently shipped to the field.
  • Action
    Stryker Orthopaedics notified their branches via email on 6/25/2015. Notification letters and Product Accountability Forms were mailed to Stryker Branches/Agencies on 817/2015 and hospital risk management on 8/18/2015.

Device

Device Recall Stryker Orthopaedics
  • Model / Serial
    Lot Code 3Y0KHP
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in WI.
  • Product Description
    Trident 10 degrees X3 Insert 36 mm ID || Catalog #623-10-36I || Hip implant component
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA