Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AMENDIA Omega Lumbar Interbody Fusion Device

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall AMENDIA Omega Lumbar Interbody Fusion Devicesee related information
Date Initiated by FirmApril 16, 2018
Create DateMay 23, 2018
Recall Status1 Open3, Classified
Recall NumberZ-1912-2018
Recall Event ID 79889
510(K)NumberK150395 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductAMENDIA 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
FEI Number 3007970248
Recalling Firm/
Manufacturer		 Spinal Elements
1755 W Oak Pkwy
Marietta GA 30062-2260
For Additional Information ContactJason 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
ActionThe 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 Commerce19 units
DistributionUS Distribution to the states of : FL, GA, NC, PA and CO
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MAX
-
-