Events

Recall of Device Recall SpeedLink 6.0 Transverse Connector

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
    54527
  • Event Risk Class
    Class 2
  • Event Number
    Z-0030-2011
  • Event Initiated Date
    2009-01-01
  • Event Date Posted
    2010-10-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88647
  • 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
    Spinal Interlaminal Fixation Appliance - Product Code KWP
  • Reason
    The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. there were also complaints that the cam may dislodge during tightening. the firm added additional instructions for use to reduce the probability of these two types of events.
  • Action
    The firm provided a revised surgical technique document to the Zimmer spine sales force in January, 2009. The firm will provide an Urgent Medical Device Correction notification to speedlink users through the sales force.

Device

Device Recall SpeedLink 6.0 Transverse Connector
  • Model / Serial
    10ZF, 12LX, 14ML, 16RD, 30NS, 35HS, 41HB, 44KQ, 5PC, 6AY, 6AZ, 6BA, 6BB, 7DZ and , 8BP.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution.
  • Product Description
    SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S
  • Manufacturer
    Zimmer Inc.

Manufacturer

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