Amendia, Inc dba Spinal Elements: Medical Device Recall in 2017 - (Recall #: Z-0239-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: November 13, 2017

Date Posted: December 20, 2017

Recall Number: Z-0239-2018

Event ID: 78592

Reason for Recall:

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

Status: Terminated

Product Quantity: 82 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated