Device recall
Z-2094-2016: LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375…
FDA device recall · Class II · Smith & Nephew, Inc.
Key facts
| Recall number (Z-number) | Z-2094-2016 |
|---|---|
| Recall event | 74271 |
| Product | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an… |
| Product code | KRO |
| Recalling firm | Smith & Nephew, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2019 |
| 510(k) numbers | K081111 |
| FEI number | 1020279 |
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