Events

Recall of Device Recall Stryker Orthopedics

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
    70100
  • Event Risk Class
    Class 2
  • Event Number
    Z-1043-2015
  • Event Initiated Date
    2014-12-15
  • Event Date Posted
    2015-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132247
  • 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
    Five customer complaints were received for the same batch of trident psl shells (part number 540-11-50e lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.
  • Action
    Stryker sent an Urgent Medical Device letter dated January 7, 2015, with a Recall Notification/Acknowledgement Form via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Recall Acknowledgement Form to so_m_product_field_action_response@stryker.com or fax to 1-855-251-3635. Customers should return the affected product to: Attention: Regulatory Compliance Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Customers with questions should call 201-831-6365. For questions regarding this recall call 201-831-5000.

Device

Device Recall Stryker Orthopedics
  • Model / Serial
    510K 983382  Lot code 49073501
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including NY, OH, PA, and TX.
  • Product Description
    Trident PSL HA Solid Back 50 mm || Includes Dome Hole Plug || Ref 540-11-50E || Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.
  • 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