Z-2108-2018Class II

ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled...

Name: Z-2108-2018 ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled...
Creator: Medtech Sas
Published: 2018-05-08
License: https://open.fda.gov/license/

MedTech SAS / initiated 2018-05-08 / Terminated

FDA source

MEDTECH SAS began a recall of 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... on 2018-05-08. FDA classified it as Class II and gives the reason as "Replacement of units lacking an updated device approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2108-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-08
Posted: 2018-06-07
Terminated: 2020-08-19
Recalling firm: MedTech SAS
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Replacement of units lacking an updated device approval.
FDA root cause: No Marketing Application
Action: Medtech would like to inform you of the planned removal of all ROSA 2.5 devices from the US market by 31st October 2018. The ROSA 2.5 design has been superseded by a newer generation product, ROSA Brain 3.0, and a decision has been made by Zimmer Biomet to exchange all ROSA 2.5 devices in the US market with ROSA Brain 3.0 devices. This decision has been taken in response to a regulatory clearance compliance issue, and there is no safety concern associated with this action. No specific action is required and the ROSA 2.5 can continue to be used at this time. A Medtech representative will be in contact to schedule the exchange of the RO 15 061 device with a ROSA Brain 3.0 device. For further questions, please call (574) 371-3071.
Quantity in commerce: 29 units
Distribution: US Distribution
Product codes and lots: Serial Numbers: RO 10 009, RO 10 011, RO 10 014, RO 13 023, RO 13 027, RO 14 031, RO 14 033, RO 14 035, RO 14 038, RO 14 039, RO 14 040, RO 14 041, RO 14 043, RO 15 044, RO 15 045, RO 15 046, RO 15 050, RO 15 051, RO 15 052, RO 15 053, RO 15 054, RO 15 058, RO 15 059, RO 15 060, RO 15 061, RO 15 063, RO 15 064, RO 15 067, RO 15 069

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2108-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2108-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07

Product code HAW

K101791Class IIRosa Surgical DeviceMedtech S.A.S / cleared 2010-09-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)