VGI Medical VerteLP Lateral Fusion Kit Recall: Unvalidated Cleaning Process

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Contact the company & request your remedy

Recalling firmVGI Medical, LLC10401 Belcher Rd S, N/A · Seminole, FL 33777-1415

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

VGI Medical is recalling specific lateral interbody fusion instrument kits due to an unvalidated automated cleaning process in the instructions. This could lead to improper cleaning and potential infection risks during surgical procedures.

Why it’s dangerous

The instructions for cleaning the instrument tray include an automated process that hasn't been properly tested or validated. This means the cleaning might not work as intended, increasing the risk of infection during surgery.

Who’s affected

Surgical teams using the recalled VerteLP Lateral Interbody Fusion instrument kits for spinal fusion procedures. Patients undergoing surgery with these instruments face potential infection risks.

How to tell if you have this one

Check for the specific lot numbers: LP-INSTSET-001 through VLP-INSTSET-006. Also look for individual instrument model numbers listed in the description.

Brand
VGI Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Numbers
Identify if your instrument kit contains the listed lot numbers: LP-INSTSET-001, VLP-INSTSET-002 through VLP-INSTSET-006.

✎ GovInfoNow

Questions people ask

Is there a remedy for this recall?

The official recall notice does not provide any remedy steps.

Which surgical procedures use this instrument kit?

This kit is used for lateral interbody fusion spinal procedures.

How can I tell if my instrument kit is affected?

Check for the specific lot numbers listed in the recall: LP-INSTSET-001 through VLP-INSTSET-006, or individual instrument model numbers.

Take action

Contact VGI Medical

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

✉️ Open in email

Subject: Recall Z-2100-2018 — VGI Medical VGI Medical

Hello,

I own a VGI Medical that is covered by recall Z-2100-2018 from VGI Medical.

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-2100-2018 (April 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2100-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.

VGI Medical, LLC recalls VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

Recall notice