FDA DeviceClass IINotable

FDA Recall: BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0

Date: 2026-05-13

Brand: Orthorebirth Co Ltd

Category: Medical Device

FDA Class: Class II

Description

Resorbable bone void filler falls outside standard specifications.

Hazard

Resorbable bone void filler falls outside standard specifications.

Remedy

1266

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