Z-0239-2018Class II

Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended...

Name: Z-0239-2018 Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended...
Creator: Amendia, Inc dba Spinal Elements
Published: 2017-11-13
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2017-11-13 / Terminated / root cause: labeling and UDI

FDA source

Amendia, Inc dba Spinal Elements began a recall of 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... on 2017-11-13. FDA classified it as Class II and gives the reason as "Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0239-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-13
Posted: 2017-12-13
Terminated: 2019-10-15
Recalling firm: Spinal Elements, Inc
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).
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Spinal Elements sent an Urgent Medical Device Recall letter dated November 13, 2017. Instructions included to examine inventory and quarantine affected products, complete and return the response form, arrange for return of any affected product, and to notify customers if further distributed. For further questions, please call (770) 575-5274.
Quantity in commerce: 82 units
Distribution: US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
Product codes and lots: Part No. CSF-40-12, Lot No. 132635

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0239-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0239-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13

Product code KWQ

K092531Class IISpine360 Anterior Cervical Plate SystemSpine360 / cleared 2010-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)