Device recall
Z-0970-2015: EXp Tibial Insert; Intended Use of Device(s): The Proven Gen-Flex Total Knee…
FDA device recall · Class II · Stelkast Co
Key facts
| Recall number (Z-number) | Z-0970-2015 |
|---|---|
| Recall event | 70082 |
| Product | EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient… |
| Product code | JWH |
| Recalling firm | Stelkast Co |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2015 |
| 510(k) numbers | K122883 |
| FEI number | 3004142400 |
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