Zavation ZVplasty System 20mm: Risk of Inadequate Sterilization

Take action

Contact the company & request your remedy

Recalling firmZavation220 Lakeland Pkwy · Flowood, MS 39232-9552

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Zavation is recalling its ZVplasty System 20mm surgical device (Part# VCF-1020-2) because some units may not have been properly sterilized. This poses a risk of infection during orthopedic or spinal procedures if used without proper sterilization.

Why it’s dangerous

The recall states that products distributed as sterile may not have been adequately sterilized. This means the device could be contaminated with harmful bacteria, increasing the risk of infection during surgery.

Who’s affected

Orthopedic and spinal surgery patients who received the ZVplasty System 20mm (Part# VCF-1020-2) from affected lot numbers. Surgeons and surgical teams using this device are most at risk.

How to tell if you have this one

Check for the lot numbers: 13650ZV, 13518ZV, 11677ZV, 11678ZV, or 10514ZV on the packaging. The product is a 20mm ZVplasty System used in orthopedic or spinal procedures.

Brand
Zavation
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot numbers 13650ZV, 13518ZV, 11677ZV, 11678ZV, or 10514ZV on the packaging.

✎ GovInfoNow

Questions people ask

Why is this device being recalled?

The recall states that products distributed as sterile may not have been adequately sterilized, which could lead to infection during surgery.

What should I do if I have this device?

The official recall notice does not specify a remedy or action for affected devices.

Which lot numbers are affected?

Lot numbers 13650ZV, 13518ZV, 11677ZV, 11678ZV, and 10514ZV.

Take action

Contact Zavation

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

✉️ Open in email

Subject: Recall Z-1766-2021 — Zavation Zavation

Hello,

I own a Zavation that is covered by recall Z-1766-2021 from Zavation.

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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-1766-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1766-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

Zavation recalls ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.

Recall notice