Drug recall
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage…
FDA recall event 85272 · Class II · Biomet, Inc.
Key facts
| Event ID | 85272 |
|---|---|
| Recall numbers | Z-1750-2020 |
| Recalling firm | Biomet, Inc. |
| Product type | Devices |
| Products | Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There were unknown bioburden levels prior to sterilization, which may affect sterility of the product. |
| Initiation date | Mar 13, 2020 |
| Report date | Apr 29, 2020 |
| 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: