FDAMay 1, 2025device
GM Helix Acqua Implant, Article Number: 140.985
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
What to do
FDA enforcement status: Ongoing
Brands named
straumann
UPCs
7899878024569
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAStraumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments2026-03-27
- FDAStraumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. 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
- FDAWB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM2026-01-06
- FDAEmdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;2025-10-17
- FDAGM Helix Acqua Implant, Article Number: 140.9842025-05-01
- FDAWB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.2025-04-17
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