Device recall
Z-0266-2018: The GMK knee system: designed for cemented use in total knee arthroplasty…
FDA device recall · Class II · Medacta Usa Inc
Key facts
| Recall number (Z-number) | Z-0266-2018 |
|---|---|
| Recall event | 78401 |
| Product | The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF |
| Product code | JWH |
| Recalling firm | Medacta Usa Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 20, 2018 |
| 510(k) numbers | K090988 |
| FEI number | 3006639916 |
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