Drug recall
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended…
FDA recall event 77598 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 77598 |
|---|---|
| Recall numbers | Z-0096-2018 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Possible break in the connector of the Force Sensor. |
| Initiation date | Dec 18, 2013 |
| Report date | Nov 22, 2017 |
| Termination date | Jun 29, 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: