Drug recall
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and…
FDA recall event 72809 · Class II · Encore Medical, Lp
Key facts
| Event ID | 72809 |
|---|---|
| Recall numbers | Z-0626-2016 |
| Recalling firm | Encore Medical, Lp |
| Product type | Devices |
| Products | AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The trial shell mating feature on the broach is undersized. |
| Initiation date | Dec 8, 2015 |
| Report date | Jan 20, 2016 |
| Termination date | Mar 1, 2016 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 1000116912 |
At a glance
- 1–9 Products in this recall
- 10–99 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: