FDA Medical Device Recalls (openFDA)
MEDTECH SAS: 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.
- Recall number
- Z-2108-2018
- 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.
- Status
- Terminated
- Initiated
- 2018-05-08
- Posted
- not on file
- Terminated
- 2020-08-19
- Reason
- Replacement of units lacking an updated device approval.
- 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 The ROSA 2.5 design has been superseded by a newer generation product, ROSA Brain 3.0, and a decision has been made by Zimmer Biomet to exchange all ROSA 2.5 devices in the US market with ROSA Brain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
- 29 units
- Distribution
- US Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K101791"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3009185973
- Firm city
- Montpellier
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28