Recall Z-1754-2017 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurological procedure in which the use of stereotactic surgery may be appropriate.
| Date | Mar 27, 2017 (initiated Feb 27, 2017) |
| Status | Terminated |
| Reason | Unapproved change made by the supplier. |
| Root cause | Component change control |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall Correction letter on February 27, 2017,to all affected customers informing them of the following: Description of the issue: A robot arm file parameter linked to arm calibration was modified by the robot arm supplier without notification to MEDTECH. As a result, once the robot arm is on trajectory, an error leading to a device reboot may decrease the devices applicative accuracy, one of the essential performance requirements, to a level above the specification. This may happen after a shutdown of the device, (voluntary or due to an error), wi |
| Quantity | 16 |
| Distribution | Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151359 | ROSA Brain Medtech S.A, Dec 18, 2015 |