Device recall
Z-0131-2016: AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-0131-2016 |
|---|---|
| Recall event | 72208 |
| Product | 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 or cementless use. This device may also be indicated in the salvage of previously failed surgical… |
| Product code | PHX |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 10, 2017 |
| 510(k) numbers | K141990 |
| FEI number | 1000116912 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database