Recall Z-1755-2017 ยท OLO Orthopedic Stereotaxic Instrument
Zimmer Biomet, Inc.
MEDTECH ROSA Spine 1.0.2 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 during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be ident
| 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 | 1 |
| 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
| K151511 | ROSA Spine Medtech S.A, Jan 4, 2016 |