AMENDIA Omega Lumbar Interbody Fusion Device recall
AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed…
Why was AMENDIA Omega Lumbar Interbody Fusion Device recalled?
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 140760
- 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…
- Recalling firm
- Spinal Elements
- Quantity
- 19 units
- Distribution
- US Distribution to the states of : FL, GA, NC, PA and CO
- Recall date
- May 30, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)