Recall Z-1156-2020— Medicrea International

Name: FDA recall Z-1156-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-02

Class II · Terminated

Class II FDA medical device recall by Medicrea International, initiated 2019-10-02, terminated 2021-02-08. It names one FDA 510(k) clearance: K163595. Product: Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010. Reason: Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter.

Recalling firm: Medicrea International
Classification: Class II
Status: Terminated
Initiated: 2019-10-02
Terminated: 2021-02-08
Firm location: Rillieux La Pape, France

510(k) clearances named in this recall

1 on FDA's record

K163595 — IMPIX 3D Print CagesMedicrea International SA·cleared 2017-11-13

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

Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

Reason for recall

Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

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