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Recall Observatory FDA recall evidence

Device product

GIZA Vertebral Body Replacement

Z-2072-2017

March 17, 2017

Class II

Product summary

Firm
Eden Spine Europe SA
Event
Event 76852
Status
Terminated
Classification
Class II
Quantity
1,839
Official record key
device-enforcement:Z-2072-2017

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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