Z-2072-2017Class II

GIZA Vertebral Body Replacement

Name: Z-2072-2017 GIZA Vertebral Body Replacement
Creator: Eden Spine Europe SA
Published: 2017-03-17
License: https://open.fda.gov/license/

Eden Spine Europe SA / initiated 2017-03-17 / Terminated / root cause: labeling and UDI

FDA source

Eden Spine Europe SA began a recall of GIZA Vertebral Body Replacement on 2017-03-17. FDA classified it as Class II and gives the reason as "Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2072-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-17
Posted: 2017-05-12
Terminated: 2020-01-06
Recalling firm: Eden Spine Europe SA
Product: GIZA Vertebral Body Replacement
Product code: MQP Spinal Vertebral Body Replacement Device
Reason for recall: Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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: [email protected] stating that this notice was received. For any questions you may contact: Christophe Zuanon, Regulatory Affairs & Quality Assurance Manager [email protected] Manager, [email protected]
Quantity in commerce: 1,839
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2072-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2072-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12

Product code MQP

K112429Class IIGiza(r) Vertebral Body ReplacementEden Spine, LLC / cleared 2012-01-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)