Drug recall
Dual Mobility Vivacit-E Bearing, Model Number 110031009
FDA recall event 86404 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 86404 |
|---|---|
| Recall numbers | Z-0057-2021 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | Dual Mobility Vivacit-E Bearing, Model Number 110031009 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. |
| Initiation date | Aug 14, 2020 |
| Report date | Oct 14, 2020 |
| Termination date | Jun 9, 2022 |
| 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: