Device recall
Z-0790-2019: Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF…
FDA device recall · Class II · XTANT MEDICAL INC
Key facts
| Recall number (Z-number) | Z-0790-2019 |
|---|---|
| Recall event | 81899 |
| Product | Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF… |
| Product code | MAX |
| Recalling firm | XTANT MEDICAL INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2021 |
| 510(k) numbers | K170119 |
| FEI number | 3005031160 |
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