Events

Recall of PathFinder end screw extender sleeve.

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
    54550
  • Event Risk Class
    Class 2
  • Event Number
    Z-0075-2011
  • Event Initiated Date
    2010-04-13
  • Event Date Posted
    2010-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88702
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Reason
    The tip of the pathfinder end screw extender sleeve has fractured during use. in some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip.
  • Action
    Zimmer Spine issued an "Urgent Medical Device Correction" letter through the Zimmer Spine sales force to be provided to PathFinder system users in February 2010. the letter identified the affected product, safety issue, and actions to be taken by customers. Customers will receive replacement devices with a design change for the recalled devices, as they are available from the manufacturer.

Device

PathFinder end screw extender sleeve.
  • Model / Serial
    20XH, 21SM, 25WG, 29CS, 29YL, 31TL, 32SQ, 33ZK, 34LG, 34XW, 35JW, 36WE, 39BH, 43MP, 44WR, 47EX, 48GF, 48LM, 48MB, 50GD and 50GE.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: USA including states of AZ, CA, CO, FL, GA, LA, MI, MN, MO, NC, NH, NY, OH, OK, PA, TN, TX, WA, and WI, and the countries of Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, France, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey, UK and Switzerland.
  • Product Description
    Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)
  • Manufacturer
    Zimmer Inc.

Manufacturer

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