Device recall
Z-0135-2021: EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size…
FDA device recall · Class II · Encore Medical, LP
Key facts
| Recall number (Z-number) | Z-0135-2021 |
|---|---|
| Recall event | 86450 |
| Product | EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. |
| 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