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

Hazard

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

Details from the source

Reason for recall: The possibility for this product that is intended for demonstration purposes only to be placed in patients. Distribution: US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA. Quantity: 61 units Lot/code info: 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;

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.