Recall Z-0546-2020— SPINEART SA

Name: FDA recall Z-0546-2020
Creator: U.S. Food and Drug Administration
Published: 2019-02-05

Class III · Terminated

Class III FDA medical device recall by SPINEART SA, initiated 2019-02-05, terminated 2021-04-28. It names one FDA 510(k) clearance: K153621. Product: Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures. Reason: Inner blister pack label is incorrect and does not match the correct external box label..

Recalling firm: SPINEART SA
Classification: Class III
Status: Terminated
Initiated: 2019-02-05
Terminated: 2021-04-28
Firm location: Plan-Les-Ouates, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K153621 — Juliet® TiSpineart·cleared 2016-07-15

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

Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

Reason for recall

Inner blister pack label is incorrect and does not match the correct external box label.

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