Device recall
Z-1249-2015: EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT…
FDA device recall · Class II · Microport Orthopedics INC.
Key facts
| Recall number (Z-number) | Z-1249-2015 |
|---|---|
| Recall event | 70477 |
| Product | EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component. |
| Product code | JWH |
| Recalling firm | Microport Orthopedics INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 19, 2015 |
| 510(k) numbers | K093552 |
| FEI number | 3010536692 |
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