TriMed Hex Cortical Screw 4.: Shorter Than Design - Recall

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Recalling firmTriMed Inc.27533 Avenue Hopkins, N/A · Santa Clarita, CA 91355-3910

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

TriMed is recalling a specific ankle bone screw that is shorter than it should be. This could mean the screw doesn't hold fractures securely during healing, potentially causing the bone to move.

Why it’s dangerous

The screw is shorter than designed, so it may not hold the broken bone securely. This could lead to the bone shifting during healing, which might require additional surgery.

Who’s affected

Patients who received this screw as part of an ankle fracture fix during surgery are likely affected. Surgeons and medical staff who used this screw in procedures are at highest risk.

How to tell if you have this one

Check if your ankle fixation system includes the TriMed Hex Cortical Screw 4.0, 40mm (REF HEX4.0-40). This screw is non-sterile and labeled 'RX' for prescription use.

Brand
TriMed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Your Implant
Look for the screw model and reference number on your ankle fixation system.

✎ GovInfoNow

Questions people ask

Is this screw dangerous?

The screw is shorter than designed, which may not hold bones securely during healing. However, the recall indicates it's low risk.

Do I need to do anything?

The recall does not specify a remedy, so no action is required unless you have the specific screw model.

How can I tell if I have this screw?

Check for the model 'Hex Cortical Screw 4.0, 40mm (REF HEX4.0-40)' on your ankle fixation system.

Take action

Contact TriMed

We’ve drafted a message you can send TriMed to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1214-2019 — TriMed TriMed

Hello,

I own a TriMed that is covered by recall Z-1214-2019 from TriMed.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1214-2019 (August 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1214-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

TriMed Inc. recalls TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System.

Lower-risk recall