Drug recall
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the…
FDA recall event 78443 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 78443 |
|---|---|
| Recall numbers | Z-0177-2018 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device. |
| Initiation date | Oct 29, 2015 |
| Report date | Dec 6, 2017 |
| Termination date | Jun 16, 2020 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1000220733 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: