Zav: 10G Cement Delivery Kit May Not Be Sterile for Spinal Procedures

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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 10G single cement delivery kits (5 fillers) used in spinal and orthopedic procedures because some kits may not have been properly sterilized. This could lead to infection risks for patients during surgery.

Why it’s dangerous

The kits may not have been adequately sterilized during manufacturing, which could lead to infections if used in surgical procedures. This is a potential contamination risk rather than an immediate hazard.

Who’s affected

Patients undergoing spinal or orthopedic procedures using the recalled kits. Medical staff handling the kits may also be at risk if the kits are not properly sterilized.

How to tell if you have this one

The product is labeled '10G SINGLE CEMENT DELIVERY KIT (5 FILLERS)' for use in orthopedic or spinal procedures. It was distributed by Zavation and is pending recall.

Brand
Zavation
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Label
Look for the label '10G SINGLE CEMENT DELIVERY KIT (5 FILLERS)' on the kit for use in orthopedic or spinal procedures.

✎ GovInfoNow

Questions people ask

Is this kit safe to use?

The recall states that products distributed as sterile may not have been adequately sterilized, so they are not safe for use in procedures.

How can I tell if I have the recalled kit?

The kit is labeled '10G SINGLE CEMENT DELIVERY KIT (5 FILLERS)' for use in orthopedic or spinal procedures.

What should I do if I have the kit?

The recall does not specify a remedy, so contact Zavation directly for guidance.

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-1740-2021 — Zavation Zavation

Hello,

I own a Zavation that is covered by recall Z-1740-2021 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-1740-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1740-2021 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 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.

Lower-risk recall