Device recall
Z-1929-2020: EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026…
FDA device recall · Class II · Encore Medical, LP
Key facts
| Recall number (Z-number) | Z-1929-2020 |
|---|---|
| Recall event | 85376 |
| Product | EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease… |
| Product code | LPH |
| Recalling firm | Encore Medical, LP |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190057 |
| 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