🔍 RecallPedia

GIZA Vertebral Body Replacement

Class I - Dangerous
🏥 Medical Devices Recalled: March 17, 2017 Eden Spine Europe SA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Eden Spine Europe SA
Reason for Recall:
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

GIZA Vertebral Body Replacement

Product Codes/Lot Numbers:

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

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2072-2017