Orthorebirth ZENBONE Bone Filler: Resorbable Material Falls Outside Specs

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Recalling firmOrthorebirth Co Ltd3 Chome 17-43, Chigasakihigashi; Tsuzuki · Yokohama, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Orthorebirth is recalling specific ZENBONE bone void fillers because the resorbable material may not meet standard specifications. This could affect medical safety and proper healing.

Why it’s dangerous

The resorbable bone void filler may not meet standard specifications, which could lead to improper healing or medical complications. Without meeting specifications, the material might not function as intended in the body.

Who’s affected

Patients who received these specific ZENBONE bone fillers during medical procedures are likely affected. Those with the model numbers ORB-0320C-Z, ORB-0310C-Z, or ORB-0304C-Z are at risk.

How to tell if you have this one

Check for the model numbers ORB-0320C-Z, ORB-0310C-Z, or ORB-0304C-Z on the product. The product also has a unique identifier 04573190050637 and was sold in specific lots: 25F07104JF, 25F07105JF, 25F07106JF.

Brand
Orthorebirth
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model number and lot number to confirm if your ZENBONE product is affected.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the material may not meet specifications, but no specific safety details are provided in the official notice.

What should I do if I have this product?

The official notice does not specify a remedy, so contact Orthorebirth directly for guidance.

How can I tell if my product is recalled?

Check for model numbers ORB-0320C-Z, ORB-0310C-Z, or ORB-0304C-Z, and lot numbers 25F07104JF, 25F07105JF, or 25F07106JF.

Take action

Contact Orthorebirth

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

✉️ Open in email

Subject: Recall Z-2132-2026 — Orthorebirth Orthorebirth

Hello,

I own a Orthorebirth that is covered by recall Z-2132-2026 from Orthorebirth.

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-2132-2026 (March 25, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2132-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.

Orthorebirth Co Ltd recalls ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Recall notice