Events

Recall of Device Recall Restoration (TM) ADM Trial Cup Holder

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
    54478
  • Event Risk Class
    Class 2
  • Event Number
    Z-1201-2010
  • Event Initiated Date
    2010-01-21
  • Event Date Posted
    2010-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88560
  • 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
    Trial Cup Holder - Product Code MEH
  • Reason
    The restoration adm trial cup holder may not have been assembled correctly.
  • Action
    An "URGENT PRODUCTION OPERATION" letter dated January 21, 2010, was sent to customers via FedEx. The letter described the product, problem and actions to be taken by customer. The customers should follow the instructions on the enclosed PRODUCT BULLETIN. The customer should check their internal inventory immediately and quarantine all affected devices, identify if the device is correctly assembled and complete the Product Correction Acknowledgement Form and fax it to (201) 831-6069. If you have any questions, feel free to contact Rich Wolyn, Manager, Divisional Regulatory Reporting at (201) 831-5158.

Device

Device Recall Restoration (TM) ADM Trial Cup Holder
  • Model / Serial
    Catalog number: 1235-0-000; Lot number: G2546019
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: AZ, CA and OR
  • Product Description
    Howmedica Restoration ADM Trial Cup Holder; || Non Sterile; || Benoist Girard, Cedex, France; || Distributed by Howmedica Osteonics Corp. || Mahwah, NJ. || The intended use: The Restoration ADM Window Trial is locked onto the Restoration ADM Trial Cup Holder and placed into the acetabulum to evaluate the size and congruity of the preparation for visualization and assessment of fit, contact and congruency of the trial within the acetabulum.
  • 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