Z-0582-2026Class II

Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10

Name: Z-0582-2026 Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10
Creator: Straumann USA LLC
Published: 2025-10-17
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2025-10-17 / Open, Classified

FDA source

Straumann USA LLC began a recall of Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10 on 2025-10-17. FDA classified it as Class II and gives the reason as "The possibility for this product that is intended for demonstration purposes only to be placed in patients". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0582-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-17
Posted: 2025-11-21
Recalling firm: Straumann USA, LLC
Product: Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Product code: NQA Biologic Material, Dental
Reason for recall: The possibility for this product that is intended for demonstration purposes only to be placed in patients.
FDA root cause: Under Investigation by firm
Action: On October 17, 2025 Urgent Field Safety Action letters were sent to customers. Action to be taken: 1. 1. Check your inventory for the affected article/lot numbers. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. Please return the affected items to the attention of Jennifer Jackson at Straumann USA, LLC for credit as indicated on the Customer Confirmation Form. 2. 2. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided. Transmission of the Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. The Food and Drug Administration (FDA) has been informed about this Field Safety Corrective Action. We apologize for any inconvenience that this may cause.
Quantity in commerce: 61 units
Distribution: US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
Product codes and lots: 1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0582-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0582-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-21

Product code NQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)