Marietta, GA, United States
Spinal Elements recalls
1 recall recorded since 2018, most recently on 16 April 2018. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 April 2018
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1912-2018
- 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 skeletal
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.