Device recall
Z-0117-2021: AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part…
FDA device recall · Class II · Encore Medical, LP
Key facts
| Recall number (Z-number) | Z-0117-2021 |
|---|---|
| Recall event | 86395 |
| Product | AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. |
| Product code | KWS |
| Recalling firm | Encore Medical, LP |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2024 |
| 510(k) numbers | K172351 |
| FEI number | 1000116912 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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