Avitus Bone Harvester Recall: Sterile Pouch Breach Risk

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Recalling firmAvitus Orthopaedics, Inc.400 Farmington Ave Ste 2826, N/A · Farmington, CT 06032-1913

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Avitus Orthopaedics is recalling bone harvesters that may have a breach in the sterile barrier pouch. This could compromise sterility during surgery, potentially leading to infections.

Why it’s dangerous

The sterile barrier pouch may develop a breach during manufacturing, which could compromise the device's sterility. If the pouch is not sterile, surgical procedures might lead to infections in the patient.

Who’s affected

Surgical teams using the Avitus Bone Harvester with filter insert (model BH-210) for bone marrow procedures. Patients undergoing surgery with this device are at risk of infection if the pouch breach occurs.

How to tell if you have this one

Check for the model BH-210 with lot numbers Z2458287A (exp. 2018-06-01) or Z2458379A (exp. 2018-10-01). The device is used for harvesting cancellous bone and bone marrow.

Brand
Avitus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Sterility
Verify if the sterile pouch is intact; if damaged, stop using the device immediately.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The device may have a breach in the sterile pouch, which could compromise sterility during surgery. If the pouch is damaged, it should not be used.

What should I do if I have this device?

Check if the sterile pouch is intact. If damaged, stop using it immediately. The manufacturer does not provide a specific remedy for this recall.

How can I tell if I have the recalled model?

Look for model BH-210 with lot numbers Z2458287A (exp. 2018-06-01) or Z2458379A (exp. 2018-10-01).

Take action

Contact Avitus

We’ve drafted a message you can send Avitus to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1047-2019 — Avitus Avitus

Hello,

I own a Avitus that is covered by recall Z-1047-2019 from Avitus.

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-1047-2019 (February 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1047-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Avitus Orthopaedics, Inc. recalls Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number:

Lower-risk recall