Drug recall
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless…
FDA recall event 72208 · Class II · Encore Medical, Lp
Key facts
| Event ID | 72208 |
|---|---|
| Recall numbers | Z-0131-2016 |
| Recalling firm | Encore Medical, Lp |
| Product type | Devices |
| Products | AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw. |
| Initiation date | Sep 15, 2015 |
| Report date | Oct 28, 2015 |
| Termination date | Jan 10, 2017 |
| 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: