Drug recall
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the…
FDA recall event 87989 · Class II · Exactech, Inc.
Key facts
| Event ID | 87989 |
|---|---|
| Recall numbers | Z-1977-2021 |
| Recalling firm | Exactech, Inc. |
| Product type | Devices |
| Products | Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat… |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The HAT trial contains a retaining ring that has shown the potential to disengage during use. |
| Initiation date | May 11, 2021 |
| Report date | Jul 7, 2021 |
| City | Gainesville |
| State | FL |
| Country | United States |
| FEI number | 1038671 |
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: