FDA recall Z-1912-2018

Spinal Elements · Class II · device

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

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

Key facts

Status
Ongoing
Initiation date
2018-04-16
Report date
2018-05-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1912-2018