Amendia, Inc dba Spinal Elements recalls Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provid…

Recall date

November 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0239-2018

FDA classification

Class II

Brand / firm

Amendia, Inc dba Spinal Elements

Sold / distributed

US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.

Why it was recalled

Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).