Events

Recall of Knowles Pin

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
    27484
  • Event Risk Class
    Class 2
  • Event Number
    Z-0118-04
  • Event Initiated Date
    2003-10-15
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30096
  • 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
    Pin, Fixation, Threaded - Product Code JDW
  • Reason
    The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.
  • Action
    All affected U.S. accounts were sent a letter dated October 15, 2003 by certified mail, return receipt requested. The seven foreign initial consignee accounts were notified via electronic mail. Customers were asked to return non-implanted product and to advise the implanting surgeons of the problem so that they may take appropriate action in regard to their patients.

Device

Knowles Pin
  • Model / Serial
    Lots 54382100, 54396500, 54987200, 55416900, 60010924, 60023409 and 60028438.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The majority of the pins were distributed within the United States. Distribution also occured in seven foreign countries; Taiwan, Canada, Japan, Korea, Belgium, Australia and Finland.
  • Product Description
    Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 inches in length. Catalog # 281-01-03.
  • Manufacturer
    Zimmer Inc

Manufacturer

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