Zavation ZVplasty System 15mm: Risk of Inadequate Sterilization

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Recalling firmZavation220 Lakeland Pkwy · Flowood, MS 39232-9552

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Zavation is recalling certain 15mm ZVplasty surgical systems used in orthopedic and spinal procedures because some products may not have been properly sterilized. This could lead to infections if used in surgery.

Why it’s dangerous

The products may not have been adequately sterilized, meaning they could carry harmful bacteria or other contaminants. If used in surgery, this could lead to infections in patients.

Who’s affected

Surgical teams and hospitals that use the recalled ZVplasty systems for orthopedic or spinal procedures. Patients undergoing surgery with these systems are at risk of infection.

How to tell if you have this one

Check for part numbers VCF-1015-2 or VCF-1015-2A with specific lot numbers listed in the recall notice. These systems are used in orthopedic and spinal procedures.

Brand
Zavation
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Review the part numbers and lot numbers to confirm if your ZVplasty system is affected.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The products may not have been adequately sterilized, which could lead to infections during surgery.

What part numbers are affected?

Part numbers VCF-1015-2 and VCF-1015-2A with specific lot numbers listed in the recall notice.

How can I check if my product is recalled?

Check the part numbers and lot numbers on your ZVplasty system against the list provided in the recall notice.

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-1762-2021 — Zavation Zavation

Hello,

I own a Zavation that is covered by recall Z-1762-2021 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.

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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-1762-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1762-2021 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, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.

Lower-risk recall