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Straumann USA LLC

Straumann USA LLC Recalls

All product recalls associated with Straumann USA LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–6 of 6 recalls

Emdogain (Straumann) – Unintended Patient Use Risk (2025)

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

Moderate

FDAOct 17, 2025Nationwide• Straumann USA LLC

GM Helix Acqua Implant (Straumann) – Incorrect Implant Size (2025)

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

Moderate

FDAMay 1, 2025Nationwide• Straumann USA LLC

Straumann Healing Abutment (Straumann) – Blister Labeling (2025)

Incorrect blister labelling.

Moderate

FDAApr 17, 2025Nationwide• Straumann USA LLC

Straumann Initial Drill (Straumann) – Laser Engraving (2025)

The referred batch was produced without the laser engraving of 7 mm.

Moderate

FDAApr 14, 2025Nationwide• Straumann USA LLC

TLX/TLC Implant Driver (Straumann) – depth marking missing (2025)

The devices are missing the laser marked depth markings.

Moderate

FDAMar 8, 2025Nationwide• Straumann USA LLC

Straumann USA LLC: KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabri...

Product label intended for the European community was distributed to the USA market via their US distribution organization

Moderate

FDAJun 25, 2021Nationwide• Straumann USA LLC