Home / Recalls / Amendia, Inc dba Spinal Elements / Z-0239-2018

Z-0239-2018 Class II Terminated

Recalled by Amendia, Inc dba Spinal Elements — Marietta, GA

Recall Details

Product Type
Devices
Report Date
December 20, 2017
Initiation Date
November 13, 2017
Termination Date
October 15, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
82 units

Product Description

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).

Reason for Recall

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

Distribution Pattern

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

Code Information

Part No. CSF-40-12, Lot No. 132635