FDAApril 16, 2018device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.

What to do

FDA enforcement status: Ongoing

Brands named

spinal elementsspinal

UPCs

7200209281211

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

FDA1) Madeline's Patisserie 2.5 ounce Chocolate Croissant, Net Wt. 3 lbs. 8 oz. (1,587.6g), packaged in a food safe polypropylene bag and packed in a food service case; 24 per case 2) Madeline's Patisserie 3.5 ounce Chocolate Croissant, Net Wt. 4 lbs. 11 oz. (2,126.2g), packaged in a food safe polyp...2025-05-16
FDA1) Madeline's Patisserie 2.5 ounce Raspberry Croissant, Net Wt. 4 lbs. (1,814.37 g), packaged in a food safe polypropylene bag and packed in a food service case; 24 per case 2) Madeline's Patisserie 3.5 ounce Raspberry Croissant, Net Wt. 6 lbs. 10 oz. (3,005.05 g), packaged in a food safe polypro...2025-05-16
FDAMadeline's Patisserie 4.25 Inch Butter Croissant Bun, Net Wt. 4 lbs. 6 oz (1,984.47 g), packaged in a food safe polypropylene bag and packed in a food service case; 24 per case2025-05-16
FDASpinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined ...2018-01-18
FDAPiranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is inten...2017-11-13
FDARobin Hood All Purpose Flour 1.8kg retial Pouch 6/1.8kg retial pouches per wholesale case2017-06-08
FDASpinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mec...2015-04-09
FDATi-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.2014-12-18

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