Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0341-2018·Announced 2018-01-24

Spineart Recalls Tryptik 2 C-Plate Screw Due to Labeling Error

Spineart SA is recalling 15 units of Tryptik 2 C-Plate Self Tapping Screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (incorrect sketch) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Spineart SA is recalling 15 units of the Tryptik 2 C-Plate Self Tapping Polyaxial Screw, 4.5 mm, length 16 mm (Ref TRY-PS-45 16-S). The recall is limited to units with Lot 3-5934 that were distributed to California.

The recall was initiated because the product labeling for the Tryptik 2-C-Plate Self Tapping screw (Ref TRY-PS 40) contains a sketch or drawing of a self-drilling screw, which is incorrect for this specific self-tapping product. The Tryptik 2C-Plate Anterior Cervical Plate System is intended for temporary stabilization of the cervical spine (C2-C7) during spinal fusion.

Healthcare providers and facilities that have received these specific units should stop using them and contact Spineart SA for instructions on return or disposal. No injuries or illnesses have been reported in connection with this labeling error.

The recalled product

Product: TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-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…
Manufacturer: SPINEART SA
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
Affected units: 15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

batch: 3-5938

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 7 recalled by SPINEART SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · SPINEART SA

See all →

High
Polyaxial screws in lot 8-4528 recalled over possible incorrect labeling
FDA (Devices) · 2025-08-20
High
Cannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled
FDA (Devices) · 2025-08-20
High
Spinal Fusion Device Recall: Setscrew Insertion and Tightening Issues
FDA (Devices) · 2024-05-15
High
Lateral lumbar spine implant plate may disassemble during surgery
FDA (Devices) · 2023-05-03
High
PERLA TL Lateral Connector Open Spinal Fusion Devices Recalled for External Label Error
FDA (Devices) · 2021-07-07

Same hazard · mis labeling