Recall Z-2072-2017— Eden Spine Europe SA

Name: FDA recall Z-2072-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-17

Class II · Terminated

Class II FDA medical device recall by Eden Spine Europe SA, initiated 2017-03-17, terminated 2020-01-06. It names one FDA 510(k) clearance: K112429. Product: GIZA Vertebral Body Replacement. Reason: Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw..

Recalling firm: Eden Spine Europe SA
Classification: Class II
Status: Terminated
Initiated: 2017-03-17
Terminated: 2020-01-06
Firm location: Geneva, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K112429 — GIZA(R) VERTEBRAL BODY REPLACEMENTEden Spine, LLC·cleared 2012-01-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GIZA Vertebral Body Replacement

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.