Recall of Device Recall MAXIMIS Pedicle Screw Spinal Fixation System

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

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
    77500
  • Event Risk Class
    Class 2
  • Event Number
    Z-2874-2017
  • Event Initiated Date
    2017-06-21
  • Event Status
    Completed
  • Event Country
  • Event Source
    USFDA
  • Event Source URL
  • 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 - Product Code MNI
  • Reason
    Devices are not consistent with quality system requirements.
  • Action
    Valorem Surgical sent an Urgent Medical Device Recall letter dated June 21, 2017, informing consignees of the product removal and instructing consignees to return any product to Valorem Surgical LLC to minimize potential risk to patients. Consignees are to fill out the attached Medical Device Recall Return Response form and send it back to the firm by email at global.safety@ValoremSurgical.com or by fax at 312-275-7117, or by mail. For questions pertaining to this recall, please submit an email inquiry to global.safety@ValoremSurgical.com

Device

  • Model / Serial
    Catalog No. C060-050; Known Lot No. WNV110516
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - US including CA and VA.
  • Product Description
    PALLAS M/MAXIMIS 50mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Valorem Surgical LLC, 3963 W Belmont Ave Ste 9, Chicago IL 60618-5129
  • Source
    USFDA