FDA-Device2017-05-24Class II
GIZA Vertebral Body Replacement
Eden Spine Europe SA
Hazard
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Sold states
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
Affected count
1,839
Manufactured in
rue du 31 Decembre 41, Geneva, Switzerland
Products
GIZA Vertebral Body Replacement
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2072-2017Don't want to check this manually?
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