Zav: 10G Direct Single Access for Orthopedic Procedures May Not Be Sterile

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Contact the company & request your remedy

Recalling firmZavation220 Lakeland Pkwy · Flowood, MS 39232-9552

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Zavation is recalling a specific surgical needle used in orthopedic and spinal procedures because some units may not have been properly sterilized. This could lead to infections if used on patients.

Why it’s dangerous

The recall states that products distributed as sterile may not have been adequately sterilized. This means the needles could be contaminated with bacteria or other pathogens, potentially causing infections if used in procedures.

Who’s affected

Healthcare professionals using Zavation's 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK surgical needles for orthopedic or spinal procedures. The risk is lowest for those who have not used the affected lot.

How to tell if you have this one

Check for the lot number 20051288 on the packaging. The product is a 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK needle 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 number 20051288 on the packaging to confirm if your needle is affected.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states that products distributed as sterile may not have been adequately sterilized, so it is not safe to use without checking the lot number.

What should I do if I have this product?

Check the lot number on the packaging. If it is 20051288, stop using it and contact Zavation for further instructions.

How can I confirm if my product is affected?

The affected product is the 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK with lot number 20051288. Check the packaging for this lot number.

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-1715-2021 — Zavation Zavation

Hello,

I own a Zavation that is covered by recall Z-1715-2021 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-1715-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1715-2021 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 SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.

Lower-risk recall