FDAApril 9, 2015device
Spinal 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.
What to do
FDA enforcement status: Terminated
Brands named
spinal elementsspinal
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
- FDAAMENDIA 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...2018-04-16
- 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
- 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
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →