Straumann USA LLC: Medical Device Recall in 2025 - (Recall #: Z-0582-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 17, 2025

Date Posted: December 3, 2025

Recall Number: Z-0582-2026

Event ID: 97753

Reason for Recall:

The possibility for this product that is intended for demonstration purposes only to be placed in patients.

Status: Ongoing

Product Quantity: 61 units

Code Information:

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;

Distribution Pattern:

US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.

Voluntary or Mandated:

Voluntary: Firm initiated