Class II — Orthorebirth Co Ltd
| Recalling firm | ORTHOREBIRTH Co., Ltd. |
|---|---|
| Registered facility | ORTHOREBIRTH CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Resorbable bone void filler falls outside standard specifications. |
| Product | BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC |
| Quantity | 1266 |
| Distribution | US Nationwide distribution in the states of CA, FL. |
| Initiated | 2026-03-25 |
| Classified | 2026-05-07 |
| Recall number | Z-2131-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Orthorebirth Co Ltd (Z-2131-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98733/
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