Drug recall
Connecting Bolt, Model 14-442093
FDA recall event 80543 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 80543 |
|---|---|
| Recall numbers | Z-2875-2018 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | Connecting Bolt, Model 14-442093 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture. |
| Initiation date | Jun 18, 2018 |
| Report date | Aug 29, 2018 |
| Termination date | Mar 26, 2020 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1825034 |
At a glance
- 1–9 Products in this recall
- None 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: