Drug recall
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended…
FDA recall event 77667 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 77667 |
|---|---|
| Recall numbers | Z-0100-2018 |
| 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 | Potential failure of the optical distance sensor due to cable disconnection. |
| Initiation date | Apr 19, 2012 |
| Report date | Nov 22, 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: