FDAClass IIMay 13, 2026

Zenbone recall

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

Why was Zenbone recalled?

Resorbable bone void filler falls outside standard specifications.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF

Product
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Recalling firm
Orthorebirth Co Ltd
Quantity
20
Distribution
US Nationwide distribution in the states of CA, FL.
Recall date
May 13, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls