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ZENBONE 0.4gRecalls & reported problems

Orthorebirth CO.,Ltd. · ZENBONE is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing ZENBONE results in a cotton-like physical form. Due to its physical form, ZENBONE is flexible and can easily fill defects in appropriate amounts. · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Mar 25, 2026Open, Classified

    Resorbable bone void filler falls outside standard specifications.

    Z-2132-2026 · Root cause: Device Design · FDA record ↗

Other Filler, Bone Void, Calcium Compound devices

All Filler, Bone Void, Calcium Compound devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.