GIZA Vertebral Body Replacement recallZ-2072-2017 · Eden Spine Europe SA · initiated Mar 17, 2017

Why it was recalled

Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.

FDA root cause category: Labeling design

What the company is doing

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]

Recall details

Recall number

Z-2072-2017

Status

Terminated

Initiated by the company

Mar 17, 2017

Recalling firm

Eden Spine Europe SA

Quantity

1,839

Product code

MQP

FDA submissions

K112429

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

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

• GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 Deg

  Eden Spine Europe SA · Spinal Vertebral Body Replacement Device
  1 recall0 reports
• GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 Deg

  Eden Spine Europe SA · Spinal Vertebral Body Replacement Device
  1 recall0 reports
• GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 Deg

  Eden Spine Europe SA · Spinal Vertebral Body Replacement Device
  1 recall0 reports
• GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 Deg

  Eden Spine Europe SA · Spinal Vertebral Body Replacement Device
  1 recall0 reports
• GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 2-5 Deg

  Eden Spine Europe SA · Spinal Vertebral Body Replacement Device
  1 recall0 reports
• GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 Deg

  Eden Spine Europe SA · Spinal Vertebral Body Replacement Device
  1 recall0 reports