Drug recall
ROSA Surgical Device 2.5.8
FDA recall event 77743 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 77743 |
|---|---|
| Recall numbers | Z-0115-2018 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | ROSA Surgical Device 2.5.8 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for software to change the final tool orientation for the command position without command. |
| Initiation date | Apr 8, 2016 |
| Report date | Nov 29, 2017 |
| Termination date | Jul 13, 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: