Recall Z-0239-2018— Amendia, Inc dba Spinal Elements

Name: FDA recall Z-0239-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-13

Class II · Terminated

Class II FDA medical device recall by Amendia, Inc dba Spinal Elements, initiated 2017-11-13, terminated 2019-10-15. It names one FDA 510(k) clearance: K092531. 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).. Reason: Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm..

Recalling firm: Amendia, Inc dba Spinal Elements
Classification: Class II
Status: Terminated
Initiated: 2017-11-13
Terminated: 2019-10-15
Firm location: Marietta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K092531 — SPINE360 ANTERIOR CERVICAL PLATE SYSTEMSpine360·cleared 2010-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.