Events

Recall of Mercury Spinal System DIA 5.5 x 60mm Straight Rod

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
    53487
  • Event Risk Class
    Class 3
  • Event Number
    Z-1259-2013
  • Event Initiated Date
    2009-04-17
  • Event Date Posted
    2013-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85618
  • 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
    Spinal elements has initiated a recall for the mercury spinal system due to a raw material issue.
  • Action
    Spinal Elements sent Urgent Medical Device Recall notification letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Chief Technology Officer at Spinal Elements for questions about the recall letter.

Device

Mercury Spinal System DIA 5.5 x 60mm Straight Rod
  • Model / Serial
    Lot Number: 080594
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in OH and PA.
  • Product Description
    Mercury Spinal System DIA 5.5 x 60mm Straight Rod, || Part Number: 60101-060. || Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
  • Manufacturer
    Spinal Elements, Inc

Manufacturer

Spinal Elements, Inc
  • Manufacturer Address
    Spinal Elements, Inc, 3115 Melrose Dr, Suite 200, Carlsbad CA 92010-6690
  • Source
    USFDA