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Eden Spine Europe SA recalls GIZA Vertebral Body Replacement
Recalled May 24, 2017 · FDA recall Z-2072-2017 · Eden Spine Europe SA
Hazard
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw. · FDA Class II
Units
1,839
Sold at
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
Description
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Product
GIZA Vertebral Body Replacement
Manufacturer(s)
Eden Spine Europe SA
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →