Events

Recall of Device Recall Trident

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
    46691
  • Event Risk Class
    Class 2
  • Event Number
    Z-1170-2008
  • Event Initiated Date
    2008-01-21
  • Event Date Posted
    2008-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68171
  • 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
    hip prosthesis acetabular component - Product Code MEH
  • Reason
    Foreign material: some of the parts tested exceeded stryker orthopaedics internal acceptance criteria for manufacturing residuals.
  • Action
    Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt. The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.

Device

Device Recall Trident
  • Model / Serial
    Catalog Numbers: # 502-01-42A; 42mm; 502-01-44B, 44mm; 502-01-46C, 46mm; 502-01-48D, 48mm; 502-01-50D, 50mm; 502-01-52E, 52mm; 502-01-54E, 54mm; 502-01-56F, 56mm; 502-01-58F, 58mm;, 502-01-60G, 60mm; 502-01-62G, 62mm; 502-01-64H, 64mm; 502-01-66H, 66mm; 502-01-681, 68mm; 502-01-701, 70mm;, 502-01-72J, 72mm; 502-01-74J, 74mm.   All lot codes with expiration dates between 1/2005 and 12/2012
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution.
  • Product Description
    Trident Hemispherical Cluster; || 42mm - 74 mm || Arc Deposited; || Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA