Events

Recall of Device Recall Trabecular Metal Shoulder Instrumentation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Inc..

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
    35783
  • Event Risk Class
    Class 2
  • Event Number
    Z-1285-06
  • Event Initiated Date
    2006-06-16
  • Event Date Posted
    2006-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46943
  • 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
    shoulder prosthesis instrument - Product Code HWT
  • Reason
    During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.
  • Action
    U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem.

Device

Device Recall Trabecular Metal Shoulder Instrumentation
  • Model / Serial
    All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain.
  • Product Description
    Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 14 mm diameter, 170 mm length, non-sterile, catalog no. 4309-14-17 (00-4309-014-17).
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA