Events

Recall of Device Recall GIZA Vertebral Body Replacement

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Eden Spine Europe SA.

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
    76852
  • Event Risk Class
    Class 2
  • Event Number
    Z-2072-2017
  • Event Initiated Date
    2017-03-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154405
  • 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
    Spinal vertebral body replacement device - Product Code MQP
  • Reason
    Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
  • Action
    A correction letter to the users was sent on March 28, 2017 Stating the following: Eden Spine Europe has become aware of extremely rare incidents of disassembly of Giza devices, which is distributed by Stryker Spine in the USA. These incidents have occurred in limited situations when a surgeon has needed to unscrew the device in order to readjust the distraction. To mitigate this risk, a more precise description of the unlocking procedure in the Giza Surgical Technique was added to prevent surgeons from fully unscrewing the locking screw. POTENTIAL HAZARD In the unlikely event the Giza device was to disassemble, the potential hazard is that the surgeon may decide either to reassemble the device or change the implant to a new device. This could potentially lead to a short surgical time delay of 2 to 10 minutes. RISK MITIGATIONS Eden Spine Europe and Stryker have added the following information in the Giza Surgical Technique to mitigate the risk of disassembly of the device: Note: If adjustment is needed, the implant locking mechanism must be unscrewed 3.5 to 4 rotations from the tightened position, to free the superior cylinder from the inferior one. No more than 4 counterclockwise rotations should be applied to the locking screw, as doing so could potentially lead to disassembly of the implant's locking mechanism. The GIZATM Vertebral Body Replacement surgical technique is available on Stryke Spine's website. ACKNOWLEDGEMENT OF THIS NOTICE Please acknowledge within 5 days of receipt of this notice: - Fill out and send the following online for: https://fr.surveymonkey.com/r/5XYT3ZQ - Or Send an Email to the following address: Customer.service@edenspine.com stating that this notice was received. For any questions you may contact: Christophe Zuanon, Regulatory Affairs & Quality Assurance Manager c.zuanon@edenspine.com Manager, c.zuanon@edenspine.com

Device

Device Recall GIZA Vertebral Body Replacement
  • Model / Serial
    Part # 48291482S Cage Giza Diam 14mm, 18-22 mm, 2-5 Deg GTIN 07640167930012 Part # 48291485S Cage Giza Diam 14mm, 18-22 mm, 5-8Deg GTIN 07640167930029 Part # 48291422S Cage Giza Diam 14mm, 23-32 mm, 2-5 Deg GTIN 07640167930036 Part # 48291427S Cage Giza Diam 14mm, 23-32 mm, 7-10 Deg GTIN 07640167930043 Part # 48291432S Cage Giza Diam 14mm, 33-54 mm, 2-5 Deg GTIN 07640167930050 and  Part # 48291437S Cage Giza Diam 14mm, 33-54 mm, 7-10 Deg GTIN 07640167930067
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY
  • Product Description
    GIZA Vertebral Body Replacement
  • Manufacturer
    Eden Spine Europe SA

Manufacturer

Eden Spine Europe SA
  • Manufacturer Address
    Eden Spine Europe SA, rue du 31 Decembre 41, Geneva Switzerland
  • Source
    USFDA