Z-0339-2018Class II

TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R)...

Name: Z-0339-2018 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R)...
Creator: Spineart Sa
Published: 2017-11-27
License: https://open.fda.gov/license/

Spineart SA / initiated 2017-11-27 / Terminated / root cause: labeling and UDI

FDA source

SPINEART SA began a recall of TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is... on 2017-11-27. FDA classified it as Class II and gives the reason as "Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw". 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-0339-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-27
Posted: 2018-01-13
Terminated: 2019-08-27
Recalling firm: Spineart SA
Product: TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following: "Out of an abundance of caution", we have decided to recall the concerned products. Please carefully follow instructions detailed below: 1. Immediately examine your inventory and quarantine product subject to recall. 2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document. 3. Collect and quarantine all products. 4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: [email protected]." For further questions, please call (949) 313-6400..
Quantity in commerce: 9 units
Distribution: US Distribution to the state of : CA
Product codes and lots: batch: 3-5936

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0339-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0336-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-12
Z-0337-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-12
Z-0338-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-12
Z-0339-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-12
Z-0340-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-12
Z-0341-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-12
Z-0342-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-12

Product code KWQ

K153042Class IITRYPTIK2C-plate Anterior Cervical Plate SystemSpineart / cleared 2016-03-28

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)