Device recall
Z-2127-2016: Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-2127-2016 |
|---|---|
| Recall event | 74317 |
| Product | Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic… |
| Product code | LZO |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 26, 2019 |
| 510(k) numbers | K063279 |
| FEI number | 1038671 |
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