Events

Recall of Triathlon Tibial Baseplate

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
    53427
  • Event Risk Class
    Class 2
  • Event Number
    Z-2334-2010
  • Event Initiated Date
    2009-09-01
  • Event Date Posted
    2010-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85487
  • 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
    A lot for lot mix up occurred between the triathlon total knee system primary tibial baseplate # 4 cemented, catalog # 5520-b-400, lot sh8nt and the #2 cemented, catalog # 5520-b-200, lot sh7rp.
  • Action
    The firm, Stryker Orthopaedics, sent an "URGENT PRODUCT RECALL" letter dated September 1, 2009, via FedEx to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to examine their inventory and hospital locations to identify the affected product; retrieve and return all affected products via Inter-Org Transfer and ship to Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430; Attn: Regulatory Reporting, and attach the fluorescent orange PRODUCT REMEDIATION sticker and mark the outer box with the words "PRODUCT RECALL; complete and fax the attached Product Accountability Form and spreadsheet to (201) 831-6069 within 5 days of receipt of the notice. If you have any questions, please contact the Manager, Divisional Regulatory Reporting at (201) 831-5970.

Device

Triathlon Tibial Baseplate
  • Model / Serial
    # 4 - Catalog Number: 5520-B-400, Lot code: SH8NT; # 2 - Catalog Number: 5520-B-200, Lot Code SH7RP.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: AL, AZ, CA, MT, NJ and TX.
  • Product Description
    Triathlon Total Knee System Primary Tibial Baseplate; || Sterile, Made in Ireland. || Howmedica Osteonics || 325 Corporate Drive || Mahwah, NJ 07430 || The Triathlon system is comprised of a femoral component, tibial tray, and tibial insert that are intended to be used in total knee arthroplasty (if replacement of the articular surf ace of the patella is required, the Duracon patellar components are compatible with the Triathlon components). The Triathlon PS Total Knee System is intended to be used in situation where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon CR Total Knee System consists of a femoral component, tibial insert, and all-polyethylene patellar components that are intended to be used with the previously cleared Triathlon Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon All Polyethylene patellare components are intended to be used with the femoral components of the previously released Duracon Total Knee System, as well as the previously release Triathlon PS Femoral component in situation where replacement of the articular surface of the patella is required. The Triathlon CR Total Knee system is intended to accommodate the posterior cruciate ligament (PCL) if it is present.
  • 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