Medical device recalls Moderate risk

Orthorebirth Co Ltd recalls BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-…

Recall date
March 25, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2131-2026
FDA classification
Class II
Brand / firm
Orthorebirth Co Ltd
Sold / distributed
US Nationwide distribution in the states of CA, FL.

Why it was recalled

Resorbable bone void filler falls outside standard specifications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

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