Home / Recalls / Medical Devices
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 prov
Recalled December 20, 2017 · FDA recall Z-0239-2018 · Amendia, Inc
Hazard
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm. · FDA Class II
Units
82 units
Sold at
US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
Description
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Product
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).
Manufacturer(s)
Amendia, Inc dba Spinal Elements
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →