Drug recall
Vanguard 360 Revision Knee System Knee prostheses
FDA recall event 75235 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 75235 |
|---|---|
| Recall numbers | Z-0003-2017 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | Vanguard 360 Revision Knee System Knee prostheses |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process… |
| Initiation date | Aug 8, 2016 |
| Report date | Oct 12, 2016 |
| Termination date | Jun 5, 2017 |
| 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: