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
- Company
- Spinal Elements
- Recall Initiated
- April 16, 2018
- Recall Number
- Z-1912-2018
- Quantity
- 19 units
- Firm Location
- Marietta, GA
Reason for Recall
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
Distribution
US Distribution to the states of : FL, GA, NC, PA and CO
Lot / Code Info
Lot Number 140760
Root Cause
Labeling mix-ups
Action Taken
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.