Events

Recall of Device Recall SolitaireC Cervical Spacer System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ebi, 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
    69981
  • Event Risk Class
    Class 2
  • Event Number
    Z-0874-2015
  • Event Initiated Date
    2014-11-11
  • Event Date Posted
    2014-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132064
  • 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
    Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
  • Reason
    A design deficiency was discovered whereby the drill/awl sleeve and spring-loaded drill/awl sleeve instruments (the sleeves) allow the mating drill and awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
  • Action
    The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated 11/11/2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and remove from circulation the items consigned/loaned to your account as identified; carefully follow the instructions on the enclosed "Response Form"; complete and return Response Form via fax to 303.501.8444, and if you have further distributed these items to medical facilities, you MUST notify them of the actions. Questions related to this notice should be directed to the Sr. Quality Engineer at 518-859-3487 Monday through Friday, 8 am to 4 pm ET.

Device

Device Recall SolitaireC Cervical Spacer System
  • Model / Serial
    Part number 14-531593 Part number 14-531594  Catalog number Lot Number 14-531593 N23597  14-531594 N23599
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Solitaire-C Cervical Spacer System || a) 14-531593 Drill/Awl Sleeve || b) 14-531594 Spring-Loaded Drill/Awl Sleeve || Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
  • Manufacturer
    Ebi, Llc

Manufacturer

Ebi, Llc
  • Manufacturer Address
    Ebi, Llc, 399 Jefferson Rd, Parsippany NJ 07054-3707
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA