Device recall
Z-1912-2018: AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The…
FDA device recall · Class II · Spinal Elements
Key facts
| Recall number (Z-number) | Z-1912-2018 |
|---|---|
| Recall event | 79889 |
| Product | AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous… |
| Product code | MAX |
| Recalling firm | Spinal Elements |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150395 |
| FEI number | 3007970248 |
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