Drug recall
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and…
FDA recall event 78372 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 78372 |
|---|---|
| Recall numbers | Z-0102-2018 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An undetected shift between the information displayed in the navigation software and the actual patient anatomy |
| Initiation date | Feb 14, 2014 |
| Report date | Nov 22, 2017 |
| Termination date | Sep 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: