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, along with a bullet nose design for minimal impaction and ease of insertion. The LIF is streamlined and available in various implant sizes to fit a variety of patient anatomies and surgical preferences
Recall
- Recall Number
- Z-1912-2018
- Event Number
- 79889
- Firm
- Spinal Elements
- FEI Number
- 3007970248
- Product Code
- MAX
- Status
- Open, Classified
- Root Cause
- Labeling mix-ups
- Initiated
- April 16, 2018
- Address
- 1755 W Oak Pkwy, Marietta, GA, 30062-2260
Description
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, along with a bullet nose design for minimal impaction and ease of insertion. The LIF is streamlined and available in various implant sizes to fit a variety of patient anatomies and surgical preferences
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
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.
US Distribution to the states of : FL, GA, NC, PA and CO
19 units