Eden Spine Europe SA: Medical Device Recall in 2017 - (Recall #: Z-2072-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

GIZA Vertebral Body Replacement

Product Classification:

Class II

Date Initiated: March 17, 2017

Date Posted: May 24, 2017

Recall Number: Z-2072-2017

Event ID: 76852

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,839

Code Information:

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 Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated