Events

Recall of T2 Humerus Sterile Teflon Tube

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
    63457
  • Event Risk Class
    Class 2
  • Event Number
    Z-0610-2013
  • Event Initiated Date
    2012-08-06
  • Event Date Posted
    2012-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113931
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the t2 humerus teflon tube.
  • Action
    The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter & Acknowledgement form dated August 7, 2012 via FedEx Return Receipt to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to inform their users of this Medical Device Removal and pass this notice to all those individuals who need to be aware within their organization; return all affected products available at their location to: Stryker Osteosynthesis, 325 Corporate Drive, Mahwah, NJ 07430 REF: PFA#2012-124 or contact Stryker customer service; complete and sign the enclosed Product Recall Acknowledgement Form and Fax to 1-855-251-3635 or email to Recall Coordinator at janice.pevide@stryker.com and keep a copy of their records. If you have any questions, contact the Manager, Regulatory Compliance, at 1-201-972-2100 or email: colleen.omeara@stryker.com.

Device

T2 Humerus Sterile Teflon Tube
  • Model / Serial
    Catalog No: 1806-0073S  Lot Code:123596
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, CO, CT, IL, IN, MO, MS, NC, NJ, NY, OR,and TX; and countries of: Australia, Canada, France, Spain and United Kingdom.
  • Product Description
    Stryker Howmedica Osteonics; Stryker T2 Humerus System || Teflon Tube, sterile; REF 1806-0073S || The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed. || Stryker Stryker Trauma GmbH 24232 Schonkirchen, Germany || distributed in USA by: Howmedica Osteonics Corp., 235 Corporate Drive,
  • 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