FDA-Device2025-12-03Class IIMISBRANDING
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
FALSE CLAIMSNationwide distribution
Hazard
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Sold states
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
Affected count
61 units
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0582-2026More Straumann USA LLC recalls
- FDA-Device2026-04-01Straumann Custom Abutment Ti recalled for incorrect material composition
- FDA-Device2026-04-01Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
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