Events

Recall of Triathlon MIS AP Sizer Body

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
    45540
  • Event Risk Class
    Class 2
  • Event Number
    Z-0448-2008
  • Event Initiated Date
    2006-09-19
  • Event Date Posted
    2007-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65754
  • 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
    MIS AP Sizer Body - Product Code JWH
  • Reason
    Assembly problems: mis instruments (triathlon mis ap sizer body - left; triathlon mis sizer body - right; triathlon mis femoral adjustment block and triathlon mis modular capture) may not assemble properly.
  • Action
    Important Product Correction letters and Product Accountability Forms were sent via Federal Express on 9/19/06 with return receipt. Foreign locations were notified by a Advisory Notice. Notification letters requested that all inventory of the affected items be examined to verify that it assemble correctly. Any product that does not assemble correctly was to be returned to Stryker, Mahwah, NJ. The Product Accountability form was to be completed by each location to notify Stryker that the letter ahd been received and inventory examined. Stryker representatives were to be contacted for product replacement.

Device

Triathlon MIS AP Sizer Body
  • Model / Serial
    Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right; All lot codes
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide: USA including states of MI and IL. and countries of Australia, China, New Zealand, Singapore, France, Germany, Italy, Portugal, Spain, Sweden and UK.
  • Product Description
    Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Stryker Orthopaedics, Mahwah, New Jersey
  • 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