Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error
Spineart SA is recalling Tryptik 2 C-Plate self-tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.
What this means for you
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 and involves a labeling error (incorrect sketch) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Spineart SA is recalling 60 units of the Tryptik 2 C-Plate Self-Tapping Polyaxial Screw 4.0 mm, length 16 mm (Ref TRY-PS-40 16-S). The recall involves Lot 3-5934, which was distributed to the state of California. The product is intended for temporary stabilization of the cervical spine during spinal fusion.
The recall was initiated because the product labeling for the self-tapping screw contains a sketch or drawing of a self-drilling screw. This discrepancy in the visual representation on the label is the specific reason for the recall action.
Healthcare providers and facilities that have received this specific lot of Tryptik 2 C-Plate screws should stop using the product and contact Spineart SA for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 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
- Hazard
- Affected units
- 60
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: 3-5935
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 →Related recalls
Same manufacturer · SPINEART SA
See all →- HighPolyaxial screws in lot 8-4528 recalled over possible incorrect labeling
FDA (Devices) · 2025-08-20
- HighCannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled
FDA (Devices) · 2025-08-20
- HighSpinal Fusion Device Recall: Setscrew Insertion and Tightening Issues
FDA (Devices) · 2024-05-15
- HighLateral lumbar spine implant plate may disassemble during surgery
FDA (Devices) · 2023-05-03
- HighPERLA TL Lateral Connector Open Spinal Fusion Devices Recalled for External Label Error
FDA (Devices) · 2021-07-07
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02