Recall Z-2108-2018— MEDTECH SAS

Name: FDA recall Z-2108-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-08

Class II · Terminated

Class II FDA medical device recall by MEDTECH SAS, initiated 2018-05-08, terminated 2020-08-19. It names one FDA 510(k) clearance: K101791. Product: ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.. Reason: Replacement of units lacking an updated device approval..

Recalling firm: MEDTECH SAS
Classification: Class II
Status: Terminated
Initiated: 2018-05-08
Terminated: 2020-08-19
Firm location: Montpellier, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K101791 — ROSA SURGICAL DEVICEMedtech S.A.S·cleared 2010-09-23

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(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

Reason for recall

Replacement of units lacking an updated device approval.

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