Recall Z-0115-2018 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8
| Date | Apr 8, 2016 |
| Status | Terminated |
| Reason | Potential for software to change the final tool orientation for the command position without command. |
| Root cause | Software design |
| Action | Field Service Technicians visited consignee locations to perform system upgrades and have been completed. |
| Quantity | 64 units |
| Distribution | AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101791 | ROSA SURGICAL DEVICE Medtech S.A.S, Sep 23, 2010 |