Events

Recall of T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    28821
  • Event Risk Class
    Class 3
  • Event Number
    Z-0994-04
  • Event Initiated Date
    2004-03-31
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32562
  • 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
    Targeting device may become distorted upon repeated autoclaving.
  • Action
    On March 31, 2004 recall letters and product accountability forms were sent via FedEx.

Device

T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.
  • Model / Serial
    Lot Code: K589039; K658262; K658259; K74990; K766542.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    There were 19 consignees which are Stryker sales representatives and subsidiaries nationwide.
  • Product Description
    T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.
  • Manufacturer
    Howmedica Osteonics Corp.

Manufacturer

Howmedica Osteonics Corp.
  • Manufacturer Address
    Howmedica Osteonics Corp., 300 Commerce Court, Mahwah NJ 07430
  • Source
    USFDA