FDAMarch 23, 2018device
Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
What to do
FDA enforcement status: Terminated
Brands named
straumann manufacturingstraumann
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAStraumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments2026-03-27
- FDAStraumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments2026-03-27
- FDACustom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;2026-03-17
- FDACustom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;2026-03-17
- FDABrand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled...2026-02-19
- FDAHandy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd2026-02-18
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