Devices

Device Recall Triathlon

  • Model / Serial
    Ref. No. 5530-G-211 Lot code G9XF6  LAF974
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Canada.
  • Product Description
    Triathlon X3 CR Tibial Bearing Insert || for knee prosthesis || Size #2 - 11MM || Ref # 5530-G-211 || 2011-09 || Howmedica Osteonics Corp.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event

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

36 devices with a similar name

Learn more about the data here

Device Recall Triathlon Revision Knee
  • Model / Serial
    Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA
  • Product Description
    Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 || The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
  • Manufacturer
    Howmedica Osteonics Corp.
Device Recall Triathlon Revision Knee
  • Model / Serial
    Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
  • Product Description
    Knee Prosthesis, Sterile, Single-Use devices || Product Usage: || The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
  • Manufacturer
    Howmedica Osteonics Corp.
Device Recall Triathlon
  • Model / Serial
    Ref 5330-G-711 Lot G9XF7  LAF978
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Canada.
  • Product Description
    Triathlon X3 CR Tibial Bearing Insert || Size #7 - 11MM || Ref # 5530-G-711 || 2011-09 || Howmedica Osteonics Corp.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Triathlon
  • Model / Serial
    Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right).   Lot Codes: AP5W52 and AP7H19.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    1 Branch (NJ) with one consignee (DE).
  • Product Description
    Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
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.
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