Events

Recall of Device Recall Abbott Spine PathFinder, Cannulated Poly Screwdriver II MOD

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
    53811
  • Event Risk Class
    Class 2
  • Event Number
    Z-2335-2010
  • Event Initiated Date
    2009-01-12
  • Event Date Posted
    2010-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86568
  • 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, spina pedicle fixation - Product Code MNI
  • Reason
    The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.
  • Action
    The sales force was provided with new instructions for use on 1/12/09 and again in 05/09. On April 6, 2010 the firm sent out an Urgent Medical Device Correction to it's field representatives for distribution to it's customers. The field representatives were to distribute the forms and provide a list of the customers that recieved the recall notice. For questions or assistance, please contact Zimmer Spine at 800-326-0635.

Device

Device Recall Abbott Spine PathFinder, Cannulated Poly Screwdriver II MOD
  • Model / Serial
    All units. Lots 36WC, 39BA, 43MN, 44WP, 47FE, 18TH, 20XF, 25WE, 29CQ, 29YJ, 31TJ, 33ZH, 47RM, 48PC, 49QW, 51PF and 58SD.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide.
  • Product Description
    Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. || Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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