Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GIZA Vertebral Body Replacement Recalled by Eden Spine Europe SA Due to Complaints that implants have been disassembled by surgeons...

Date: March 17, 2017
Company: Eden Spine Europe SA
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Eden Spine Europe SA directly.

Affected Products

GIZA Vertebral Body Replacement

Quantity: 1,839

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 41 states: AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY, DC

Affected (41 states)Not affected

About Eden Spine Europe SA

Eden Spine Europe SA has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report