Reported May 13, 2026 · Ongoing

ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Orthorebirth Co. Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Orthorebirth Co Ltd · 3 Chome 17-43 · Yokohama · N/A

Is this the product you have?

  • ZENBONE
  • REF
    • ORB-0320C-Z
    • ORB-0310C-Z
    • ORB-0304C-Z
Lot codes and dates
  • UDI-DI04573190050637
  • Lots
    • 25F07104JF
    • 25F07105JF
    • 25F07106JF
Amount recalled
20

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Resorbable bone void filler falls outside standard specifications.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.