Drug recall
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning…
FDA recall event 78944 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 78944 |
|---|---|
| Recall numbers | Z-0638-2018, Z-0639-2018 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons., ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Robot arm being sent to the wrong position |
| Initiation date | May 1, 2017 |
| Report date | Feb 28, 2018 |
| Termination date | Jul 13, 2020 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1825034 |
At a glance
- 1–9 Products in this recall
- None 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: