Zavation OsteoFlex Bone Cement Recall: Sterilization Risk

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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 OsteoFlex bone cement used in orthopedic and spinal procedures because some products may not have been properly sterilized. This could lead to infections or other complications during surgery. Patients and medical professionals should check their lot numbers to see if they are affected.

Why it’s dangerous

The bone cement may not have been adequately sterilized, which could lead to infections or other complications during surgical procedures. This is a risk in medical settings where sterile conditions are critical.

Who’s affected

Medical professionals and patients using OsteoFlex bone cement for orthopedic or spinal procedures. Those with the specific lot numbers listed are most at risk.

How to tell if you have this one

Check the product's reference number (INTV-OSFL or INTV-OSFL-LV) and lot number. Affected lots include 11395ZV, 11285ZV, 11574ZV, 11471ZV for INTV-OSFL and 12386ZV for INTV-OSFL-LV.

Brand
Zavation
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Identify the lot number on the product label to determine if it is one of the affected numbers listed.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The products may not have been adequately sterilized, which could lead to infections or complications during surgical procedures.

What lot numbers are affected?

INTV-OSFL lot numbers: 11395ZV, 11285ZV, 11574ZV, 11471ZV; INTV-OSFL-LV lot number: 12386ZV.

Do I need to stop using this product?

The recall does not require immediate discontinuation; check your lot number to see if it is affected.

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-1756-2021 — Zavation Zavation

Hello,

I own a Zavation that is covered by recall Z-1756-2021 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-1756-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1756-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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 OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.

Lower-risk recall