Events

Recall of Device Recall Trident Hemispherical Acetabular Shell

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
    50097
  • Event Risk Class
    Class 2
  • Event Number
    Z-1685-2009
  • Event Initiated Date
    2007-05-29
  • Event Date Posted
    2009-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74717
  • 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 became aware that trident hemispherical shells, catalog number 508-11-74j, are actually marked and labeled as catalog number 598-11-72j, lot code 20282301.
  • Action
    Stryker Orthopaedics issued an "Important Market Withdrawal" notice via Federal Express dated May 29, 2007. Consignees were asked to locate and return affected product and fax the attached Product Accountability Form to 1-201-831-6069. For further questions, contact Stryker Orthopaedics at 1-201-831-5825.

Device

Device Recall Trident Hemispherical Acetabular Shell
  • Model / Serial
    Product Number: 508-11-72J; Lot Number: 20282301.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to 2 Stryker branches.
  • Product Description
    Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. || Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts.
  • 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