FDANovember 30, 2021device
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
What to do
FDA enforcement status: Terminated
Brands named
straumann
UPCs
7899878052722
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- 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
- 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
- FDAGM Helix Acqua Implant, Article Number: 140.9852025-05-01
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