Zav: 10G Bone Access Kit May Not Be Sterile - Recall

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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 10G DIRECT DOUBLE BONE ACCESS KIT for orthopedic and spinal 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, meaning they could carry harmful bacteria or other contaminants. If used during surgery, this could lead to infections in patients.

Who’s affected

Orthopedic and spinal surgery patients who use this kit during procedures. The risk is primarily for patients undergoing surgery with this specific kit.

How to tell if you have this one

Look for the product name '10G DIRECT DOUBLE BONE ACCESS KIT' from Zavation. This kit is used in orthopedic and spinal procedures.

Brand
Zavation
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Sterilization Status
Contact Zavation directly to verify if your kit has been properly sterilized.

✎ GovInfoNow

Questions people ask

Is this kit safe to use?

The recall states that some kits may not have been adequately sterilized, so they could pose infection risks. Always check with Zavation for verification.

How do I know if I have the recalled kit?

Look for the product name '10G DIRECT DOUBLE BONE ACCESS KIT' from Zavation used in orthopedic or spinal procedures.

What should I do if I have this kit?

Contact Zavation directly to verify if your kit has been properly sterilized. They may provide guidance on next steps.

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-1742-2021 — Zavation Zavation

Hello,

I own a Zavation that is covered by recall Z-1742-2021 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-1742-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1742-2021 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 DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.

Lower-risk recall