Recall Z-0172-2020— MEDTECH SAS

Name: FDA recall Z-0172-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-10

Class I · Terminated

Class I FDA medical device recall by MEDTECH SAS, initiated 2019-09-10, terminated 2021-11-02. It names 2 FDA 510(k) clearances: K172444, K151359. Product: Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.. Reason: The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly..

Recalling firm: MEDTECH SAS
Classification: Class I
Status: Terminated
Initiated: 2019-09-10
Terminated: 2021-11-02
Firm location: Montpellier, N/A, France

510(k) clearances named in this recall

2 on FDA's record

K172444 — ROSA BRAIN (v3.0.0.5)Medtech S.A·cleared 2018-03-28
K151359 — ROSA BrainMedtech S.A·cleared 2015-12-18

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

Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.

Reason for recall

The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.

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