Date Initiated by Firm |
April 16, 2018 |
Create Date |
May 23, 2018 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1912-2018 |
Recall Event ID |
79889 |
510(K)Number |
K150395
|
Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
|
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 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 |
Code Information |
Lot Number 140760 |
Recalling Firm/ Manufacturer |
Spinal Elements 1755 W Oak Pkwy Marietta GA 30062-2260
|
For Additional Information Contact |
Jason Blain 760-607-1812
|
Manufacturer Reason for Recall |
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
|
FDA Determined Cause 2 |
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 in Commerce |
19 units |
Distribution |
US Distribution to the states of : FL, GA, NC, PA and CO |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = MAX and Original Applicant = AMENDIA, INC.
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