Events

Recall of Device Recall Triathlon Femoral Distal Augment Left

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
    64941
  • Event Risk Class
    Class 2
  • Event Number
    Z-1370-2013
  • Event Initiated Date
    2013-03-25
  • Event Date Posted
    2013-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117473
  • 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 orthopaedics received a report that a label on the external packaging (box) of a triathalon femoral distal augment 10mm- size 5 left depicted a glyph of an acetabular shell rather than a femoral distal augment. in addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.
  • Action
    The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 25, 2013 and Product Accountability Forms via Fed Ex to its Consignees/ customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the attached Notification Acknowledgment Form within 5 days via fax to 855-251-3635; contact the hospitals in your territory that have the affected product to arrange return of product; and return affected product to the attention of Regulatory Compliance Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, attach flourescent orange PRODUCT REMEDIATION sticker to your return indicating the PR #RA2013-011 and mark outer box with the words "Product Recall". If you have any questions, feel free to contact Manager, Divisional Regulatory Compliance at (201) 972-2100.

Device

Device Recall Triathlon Femoral Distal Augment Left
  • Model / Serial
    Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.
  • Product Description
    Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package || Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA || Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 || Meyzieu, Cedex, France || This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone
  • 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