Device recall
Z-3209-2018: Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-3209-2018 |
|---|---|
| Recall event | 80763 |
| Product | Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. |
| Product code | JWH |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150890 |
| 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