Events

Recall of Device Recall SpheRx Posted Pedicle Screw System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NuVasive 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
    52634
  • Event Risk Class
    Class 2
  • Event Number
    Z-0356-2013
  • Event Initiated Date
    2009-01-05
  • Event Date Posted
    2012-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83505
  • 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 tulip portion of the screw assembly can disengage from the shank after implantation.
  • Action
    Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected. Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.

Device

Device Recall SpheRx Posted Pedicle Screw System
  • Model / Serial
    Batch: JK2083, JK2184
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
  • Product Description
    6.5mm x 35mm Cannulated Screw Shank || Subsequent Codes: KWP, KWQ, MNH, MNI
  • Manufacturer
    NuVasive Inc

Manufacturer

NuVasive Inc
  • Manufacturer Address
    NuVasive Inc, 7475 Lusk Blvd, San Diego CA 92121-5707
  • Manufacturer Parent Company (2017)
    NuVasive, Inc.
  • Source
    USFDA