FDA DeviceClass IINotable

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

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

20

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