Recall Z-1912-2018 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Spinal Elements
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 levels from L2-S1. The LIF features a self-locking expansion mechanism that is infinitely adjustable
| Date | Apr 16, 2018 |
| Status | Open, Classified |
| Reason | Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis. |
| Root cause | Labeling mix-ups |
| Action | The firm initiated the recall by letter on April 16, 2018, The firm requested return of the product. Distributors who further distributed the product were directed to notify their customers. For further questions, please call (760) 607-1812. |
| Quantity | 19 units |
| Distribution | US Distribution to the states of : FL, GA, NC, PA and CO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150395 | Omega LIF System Amendia, Inc., Aug 10, 2015 |