Device recall
Z-1941-2016: Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument…
FDA device recall · Class II · Materialise USA LLC
Key facts
| Recall number (Z-number) | Z-1941-2016 |
|---|---|
| Recall event | 74213 |
| Product | Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set. |
| Product code | JWH |
| Recalling firm | Materialise USA LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2016 |
| 510(k) numbers | K102795 |
| FEI number | 3005718816 |
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