Z-2132-2026Class II

Zenbone, Ref: Orb-0320C-Z, Orb-0310C-Z, Orb-0304C-Z

Name: Z-2132-2026 Zenbone, Ref: Orb-0320C-Z, Orb-0310C-Z, Orb-0304C-Z
Creator: Orthorebirth Co Ltd
Published: 2026-03-25
License: https://open.fda.gov/license/

Orthorebirth Co Ltd / initiated 2026-03-25 / Open, Classified / root cause: design

FDA source

Orthorebirth Co Ltd began a recall of ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z on 2026-03-25. FDA classified it as Class II and gives the reason as "Resorbable bone void filler falls outside standard specifications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2132-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-25
Posted: 2026-05-07
Recalling firm: Orthorebirth Co Ltd
Product: Zenbone, Ref: Orb-0320C-Z, Orb-0310C-Z, Orb-0304C-Z
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Resorbable bone void filler falls outside standard specifications.
Root cause tag: design
FDA root cause: Device Design
Action: On 3/25/2026, product withdrawal emails were sent to customers informing them to stop distribution and that additional information on device return would be provided. If products were distributed to distributors or hospitals, the firm requests the customer inform to stop distribution and ensure affected devices are not used. In addition, notify the firm if affected devices were used in surgery. On 4/21/2026, recall notices were emailed to customers who were asked to do the following: 1) Return affected devices to firm. 2) If devices were distributed elsewhere, recover all affected product that is in the hands of sub-distributors or end-users, and that you return all affected product to firm. 3) Complete and return the customer reply form via email to [email protected] If you have recall questions, an alternative firm contact for the recall can be found at 1-858-792-1235
Quantity in commerce: 20
Distribution: US Nationwide distribution in the states of CA, FL.
Product codes and lots: UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2132-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2131-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-07
Z-2132-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-07

Product code MQV

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)