Device recall
Z-0060-2021: DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained…
FDA device recall · Class II · Encore Medical, LP
Key facts
| Recall number (Z-number) | Z-0060-2021 |
|---|---|
| Recall event | 86257 |
| Product | DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the… |
| Product code | MBH |
| Recalling firm | Encore Medical, LP |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171991 |
| 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