Device recall
Z-1139-2017: Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-1139-2017 |
|---|---|
| Recall event | 76206 |
| Product | Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants. |
| Product code | JWH |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2017 |
| 510(k) numbers | K160342 |
| 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