Drug recall
Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System…
FDA recall event 83085 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 83085 |
|---|---|
| Recall numbers | Z-1962-2019, Z-1963-2019 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone…, Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The products do not have sufficient data to support the labeled shelf life of 10 years. |
| Initiation date | Jun 4, 2019 |
| Report date | Jul 24, 2019 |
| Termination date | Jul 21, 2021 |
| 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: