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Recall Observatory FDA recall evidence

Device product

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

Z-0582-2026

October 17, 2025

Class II

Product summary

Firm
Straumann USA LLC
Event
Event 97753
Status
Ongoing
Classification
Class II
Quantity
61 units
Official record key
device-enforcement:Z-0582-2026

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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