Recall Z-0178-2018 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8
| Date | Feb 10, 2013 |
| Status | Terminated |
| Reason | Issue with optional neuro-endoscopy module detected under specific conditions during internal testing. |
| Root cause | Software design |
| Action | Field Service Technicians were dispatched to correct units by upgrading the system to ROSA 2.5.7. A further update of ROSA 2.5.8.4. A Field Safety Notice dated 07/10/2013 notifying consignees of a risk in the ROSA system recognized in internal testing. It was suggested that consignees not utilize the neuro-endoscopy module until further notice. The recall notice should have been shared with the appropriate parties and the signed acknowledgement form returned to the recalling firm. |
| Quantity | 22 units (4 US and 18 OUS) |
| Distribution | AR, OH, MI, and TX |
| FDA record | Open on fda.gov |