FDA Medical Device Recalls (openFDA)
Eden Spine Europe SA: GIZA Vertebral Body Replacement
- Recall number
- Z-2072-2017
- Recalling firm
- Eden Spine Europe SA
- Product
- GIZA Vertebral Body Replacement
- Status
- Terminated
- Initiated
- 2017-03-17
- Posted
- not on file
- Terminated
- 2020-01-06
- Reason
- Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
- 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: 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
- Quantity
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K112429"]
- PMA numbers
- not on file
- Product code
- MQP
- Firm FEI
- 3008844415
- Firm city
- Geneva
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28