Events

Recall of Device Recall Stryker Orthopaedics Restoration Gap Plate Screw

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
    52713
  • Event Risk Class
    Class 3
  • Event Number
    Z-2134-2009
  • Event Initiated Date
    2009-06-26
  • Event Date Posted
    2009-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83759
  • 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
    Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in astm standard for titanium surgical implants.
  • Action
    Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Device

Device Recall Stryker Orthopaedics Restoration Gap Plate Screw
  • Model / Serial
    Catalog number: 2080-0015; GAP PLATE SCREWS D36MLE 18-Jul-2013 GAP PLATE SCREWS E2MMLE 21-Jul-2013 GAP PLATE SCREWS D31MLE 21-Jul-2013 GAP PLATE SCREWS D30MLE 21-Jul-2013 GAP PLATE SCREWS E2PMLE 21-Jul-2013 GAP PLATE SCREWS E2NMLE 21-Jul-2013 GAP PLATE SCREWS KM1MLE 23-Jul-2013 GAP PLATE SCREWS KM3MLE 23-Jul-2013 GAP PLATE SCREWS KM0MLE 25-Jul-2013 GAP PLATE SCREWS LH6MLE 25-Jul-2013 GAP PLATE SCREWS LH1MLE 25-Jul-2013 GAP PLATE SCREWS KM2MLE 25-Jul-2013 GAP PLATE SCREWS KM4MLE 25-Jul-2013 GAP PLATE SCREWS LH4MLE 25-Jul-2013 GAP PLATE SCREWS LEYMLE 28-Jul-2013 GAP PLATE SCREWS 7DTMNE 16-Sep-2013 GAP PLATE SCREWS 7DVMNE 16-Sep-2013 GAP PLATE SCREWS MERMH4 04-Dec-2013 GAP PLATE SCREWS MERMH7 04-Dec-2013 GAP PLATE SCREWS MERMH6 05-Dec-2013 GAP PLATE SCREWS MERMH5 08-Dec-2013 GAP PLATE SCREWS METHDN 21-Dec-2013 GAP PLATE SCREWS METHDT 21-Dec-2013 GAP PLATE SCREWS METHDP 28-Dec-2013 GAP PLATE SCREWS METKM8 30-Dec-2013 GAP PLATE SCREWS METKM7 30-Dec-2013 GAP PLATE SCREWS METHDR 06-Jan-2014
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution
  • Product Description
    Stryker Orthopaedics Restoration Gap Plate Screw; || Dia. 6.5 mm, Lnth 15 mm; || Made in USA, Sterile; || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430.
  • 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