Eden Spine Europe SA recalls GIZA Vertebral Body Replacement

Recall date

March 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2072-2017

FDA classification

Class II

Brand / firm

Eden Spine Europe SA

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GIZA Vertebral Body Replacement