Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Piranha Screw 4.0 x 12mm Recalled by Amendia, Inc dba Spinal Elements Due to Potential incorrect marking and color identification of Piranha...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Amendia, Inc dba Spinal Elements directly.
Affected Products
Piranha 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 intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).
Quantity: 82 units
Why Was This Recalled?
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Where Was This Sold?
This product was distributed to 9 states: AR, CA, GA, LA, MD, NV, NY, OH, TX
About Amendia, Inc dba Spinal Elements
Amendia, Inc dba Spinal Elements has 1 total recall tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report