Events

Recall of Device Recall Stryker Triathlon

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
    64655
  • Event Risk Class
    Class 2
  • Event Number
    Z-1061-2013
  • Event Initiated Date
    2013-02-23
  • Event Date Posted
    2013-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116723
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Stryker received reports from the field indicating that the handle detached from the cam of the baseplate impactor/extractor assembly.
  • Action
    Stryker sent Notification Letters/Product Accountablility Forms dated March 1, 2013 via FedEx to their Branches/Agencies on March 1, 2013.. Notification Letters/Product Recall Acknowledgement Forms dated March 4, 2013, were sent via FedEx to Hospital Risk Management on March 4, 2013. The Notification letters identified the product, the problem, and instructed customers on how to identify affected product; informs customers of the issues and potential hazards with the affected product and instructs them to contact their representative to arrange for return/replacement of any affected product. Customers are also asked to fax back the provided "Urgent Medical Device Removal Notification Acknowledgement Form" to Stryker within 5 days of receipt. Customers with questions were instructed to call 201-972-2100. For questions regarding this recall call 201-831-5523.

Device

Device Recall Stryker Triathlon
  • Model / Serial
    Catalog Number 6541-4-805. Lot Numbers: RD4V204; RD5V234; RD5V235; RD5V235A; RD5V235Y; RD5V236; RD5V236A; RD5V237; RD6A009; RD6A010; RD6A011; RD6A011P; RD6A012; RD6A051; RD6A052; RD6A053; RD6A053M; RD6A053T; RD6A061; RD6A061A; RD6A062; RD6A062N; RD6A063; RD6A063T; RD6A065; RD6A065D; RD6A065T; RD6A066; RD6A066A; RD6C103; RD6C103L; RD6C104; RD6C104Y; RD6C105; RD6C105M; RD6C105T; RD6C106; RD6C106A; RD6C108; RD6C109; RD6C109L; RD6C126; RD6H178; RD6H184; RD6H187; RD6L222; RD6L223; RD6L223A; RD6L224; RD6L224A; RD6L226; RD6L227; RD6L227A; RD6L227N; RD6M148; RD6M158; RD6M159; RD6M161; RD6M163; RD6M163A; RD6M163L; RD6M164; RD6M164A; RD6M165; RD6N046; RD6N046L; RD6N047; RD6N047N; RD6N048; RD6N052; RD6N052T; RD6N053; RD6N054; RD6N072; RD6N072H; RD6N073; RD6N074; RD6N074J; RD6N158; RD6N159; RD6N160; RD6S054; RD6S055; RD6S055A; RD6S056; RD6S081; RD6S082; RD6S082Y; RD6S083; RD6S083Y; RD6S084; RD6S084A; RD6S085; RD6S085Y; RD6S142; RD6S142Y; RD6S143; RD6S143A; RD6S144; RD6S144Y.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Canada, Japan, Australia, China, New Zealand, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland and the United Kingdom.
  • Product Description
    Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. || Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France || The Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery.
  • 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