Events

Recall of Device Recall NFix II System 150 mm

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

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
    50677
  • Event Risk Class
    Class 2
  • Event Number
    Z-0963-2009
  • Event Initiated Date
    2008-11-07
  • Event Date Posted
    2009-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75976
  • 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
    Pedicle screw spinal system - Product Code NQP
  • Reason
    The dimensional specifications are incorrect.
  • Action
    The recalling firm issued an e-mail on 11/18/08 to their sales force to inform them of the problem and the need to remove the product.The recalling firm issued Medical Device recall letters dated 11/19/08 to their customers to inform them of the problem and the need to return the product. Contact Synthes at 800-620-7025 ext. 7025 or 610-719-5750 for additional information.

Device

Device Recall NFix II System 150 mm
  • Model / Serial
    Lot numbers: P06J01 exp 9/30/07; P06J02 exp 9/30/07; P06M01 exp 12/31/07; P06M02 exp 12/31/07; P07D02 exp 4/30/08; P07H01 exp 8/31/08; and P07J01 exp 9/30/08.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.
  • Product Description
    NFix II System 150 mm, Catalog number NX60150-1 || spinal fusion surgery
  • Manufacturer
    Synthes Spine

Manufacturer

Synthes Spine
  • Manufacturer Address
    Synthes Spine, 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA