Device recall
Z-0573-2016: Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND…
FDA device recall · Class II · Smith & Nephew, Inc.
Key facts
| Recall number (Z-number) | Z-0573-2016 |
|---|---|
| Recall event | 72866 |
| Product | Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant. |
| Product code | JWH |
| Recalling firm | Smith & Nephew, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 17, 2016 |
| 510(k) numbers | K951987 |
| 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