Device recall
Z-2883-2026: Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA…
FDA device recall · Class II · United Orthopedic Corp.
Key facts
| Recall number (Z-number) | Z-2883-2026 |
|---|---|
| Recall event | 99026 |
| Product | Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A |
| Product code | JWH |
| Recalling firm | United Orthopedic Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K082424 |
| FEI number | 1000395711 |
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