Device recall
Z-0538-2018: Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-0538-2018 |
|---|---|
| Recall event | 78936 |
| Product | Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic… |
| Product code | MEH |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 6, 2019 |
| 510(k) numbers | K162732 |
| 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