Device recall
Z-2499-2019: Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-2499-2019 |
|---|---|
| Recall event | 83520 |
| Product | Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. |
| Product code | HWA |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2023 |
| FEI number | 1038671 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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