SPINEART TRYPTIK 2C-Plate Screws: Incorrect Labeling Risk
SPINEART recalls TRYPTIK 2C-Plate screws with batch 3-5934 due to incorrect labeling showing a self-drilling screw sketch. This may cause confusion in surgical use. Affected patients should contact SPINEART for guidance.
Lower-risk 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.
Contact the company
What happened, in plain English
SPINEART is recalling TRYPTIK 2C-Plate self-tapping screws with batch number 3-5934 because the product labeling incorrectly shows a self-drilling screw sketch. This could lead to confusion during surgical procedures, potentially affecting spinal stabilization. Read more at govinfonow.com/recall/72474-spineart-tryptik-2c-plate-screws-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72474-spineart-tryptik-2c-plate-screws-incorrect-labeling-risk · Updated September 1, 2026 · FDA enforcement record: FDA #Z-0337-2018
Cite this page
“SPINEART TRYPTIK 2C-Plate Screws: Incorrect Labeling Risk.” GovInfoNow, updated September 1, 2026. https://govinfonow.com/recall/72474-spineart-tryptik-2c-plate-screws-incorrect-labeling-risk. Based on FDA recall #Z-0337-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0337-2018%22&limit=1).
Why it’s dangerous
The product labeling for these screws incorrectly includes a sketch of a self-drilling screw instead of the intended self-tapping screw. This could cause confusion during surgical procedures, potentially leading to improper spinal stabilization.
Who’s affected
Patients who received the TRYPTIK 2C-Plate system with batch 3-5934 for cervical spine stabilization are affected. Surgeons and medical staff using this specific batch are at highest risk.
How to tell if you have this one
Check for the batch number 3-5934 on the TRYPTIK 2C-Plate system packaging. The product is intended for temporary cervical spine stabilization in patients with spinal instability.
- Brand
SPINEART- Category
Medical device
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Distribution to the state of : CA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0336-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 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.; batch: 3-8869, 3-5933 | 54 units |
| Z-0337-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-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.; batch: 3-5934 | 120 units |
| Z-0338-2018 | 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 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.; batch: 3-5935 | 60 units |
| 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) 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.; batch: 3-5936 | 9 units |
| Z-0340-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-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.; batch: 3-5937 | 16 units |
| Z-0341-2018 | 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 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.; batch: 3-5938 | 15 units |
| Z-0342-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-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.; batch: 3-5939 | 8 units |
What to do — step by step
Contact SPINEART
Reach out to SPINEART directly for guidance on the recalled product and next steps.
Where it went and when
Where it was distributed
Distributed in California.
FDA distribution: “US Distribution to the state of : CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury from this product?
The recall is due to labeling confusion, not an immediate safety hazard. The risk is low and related to potential surgical errors.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0337-2018 (November 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0337-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 1, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.