Recall Z-2108-2018 ยท HAW Neurological Stereotaxic Instrument
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.
| Date | May 8, 2018 |
| Status | Terminated |
| 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 The ROSA 2.5 design has been superseded by a newer generation product, ROSA Brain 3.0, and a decision has been made by Zimmer Biomet to exchange all ROSA 2.5 devices in the US market with ROSA Brain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 |
| Quantity | 29 units |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101791 | ROSA SURGICAL DEVICE Medtech S.A.S, Sep 23, 2010 |