Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GM Helix Acqua Implant Recalled by Straumann USA LLC Due to It is possible that a package labelled as...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Straumann USA LLC directly.
Affected Products
GM Helix Acqua Implant, Article Number: 140.984
Quantity: 300 units (125 US, 175 OUS)
Why Was This Recalled?
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Straumann USA LLC
Straumann USA LLC has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report