Warning
Orthorebirth Co Ltd Recalls ZENBONE
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2132-2026Medical Device
Orthorebirth Co Ltd Recalls ZENBONE
Orthorebirth Co Ltd · Class II — Moderate Risk
Product Description
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Reason for Recall
Resorbable bone void filler falls outside standard specifications.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the states of CA, FL.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database