Orthorebirth Co Ltd FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-ZClass IIMar 25, 2026Resorbable bone void filler falls outside standard specifica	Resorbable bone void filler falls outside standard specifications.	Class IIDevices	Mar 25, 2026
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KClass IIMar 25, 2026Resorbable bone void filler falls outside standard specifica	Resorbable bone void filler falls outside standard specifications.	Class IIDevices	Mar 25, 2026