Events

Recall of Device Recall Triathlon PKR Insert X3 1

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
    50535
  • Event Risk Class
    Class 2
  • Event Number
    Z-0869-2009
  • Event Initiated Date
    2008-11-25
  • Event Date Posted
    2009-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75714
  • 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
    Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis - Product Code HRY
  • Reason
    Label mix-up: stryker orthopaedics became aware of a lot for lot mix up between triathlon pkr insert x3 #1 lm/rl 8mm, 5630-g-108 lot code nxdmee and triathlon pkr insert x3 #1 rm/ll- 12 mm 5630-g-122 lot code m8jmee.
  • Action
    Recall notifications entitled "URGENT PRODUCT RECALL" were sent via Federal Express on 11/25/2008 to Stryker branches, hospital risk management, Hospital Chief of Orthopaedics. For further information, please contact Stryker Howmedica Osteonics Corporation by telephone at 201-831-5718.

Device

Device Recall Triathlon PKR Insert X3 1
  • Model / Serial
    8 mm - LM/RL Catalog number 5630-G-108, Lot code NXDMEE; 12 mm -RM/LL Catalog number 5630-G-122 Lot code M8JMEE.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital.
  • Product Description
    Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE || Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE || Intended Use: || - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis || - Revision of previous unsuccessful surgical procedures, either involving, or || not involving, previous use of a unicompartmental knee prosthesis || - As an alternative to tibial osteotomy in patients with unicompartmental || osteoarthritis, where bone stock is of poor quality or inadequate for other || reconstructive techniques as indicted by deficiencies of the femoral || condyle/tibia plateau. || These components are intended for implantation with bone cement. || Stryker Orthopaedics; || Howmedica Osteonics Copr. || 325 Corporate Drive || Mahwah, NJ 07430
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA