Events

Recall of Mercury Spinal System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spinal Elements, 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
    70950
  • Event Risk Class
    Class 3
  • Event Number
    Z-1597-2015
  • Event Initiated Date
    2015-04-09
  • Event Date Posted
    2015-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135713
  • 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
    Some rods may not meet the appropriate traceability requirements including the lot number. some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. the lack of marking interrupts the ability to maintain traceability of the device.
  • Action
    The firm sent customer notification letters on 04/09/15. In this letter the firm requested that all affected lots be returned, and replacement inventory will be made available. The firm requested that customers take the following actions: 1. Immediately examine inventory for part number 60100-045. 2. Immediately discontinue the use and/or distribution of the affected lots 3. Send all affected product back to: Spinal Elements, Inc. ATTN: Julie Lamothe 3115 Melrose Drive Carlsbad, CA 92010 4. If further distributed the product to please identify the customers and notify them as once. 5. Complete and return the enclosed "Customer Response Form." Any questions the firm states to contact the Customer Service department at 1.877.SPINAL5 Ext. 213.

Device

Mercury Spinal System
  • Model / Serial
    Part Number: 60100-045 Lot Numbers: 140086, 140449, 141013
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.
  • Product Description
    Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.
  • Manufacturer
    Spinal Elements, Inc

Manufacturer

Spinal Elements, Inc
  • Manufacturer Address
    Spinal Elements, Inc, 3115 Melrose Dr Suite 200, Carlsbad CA 92010-6690
  • Manufacturer Parent Company (2017)
    Spinal Elements
  • Source
    USFDA