Straumann USA recalls

Straumann USA has 21 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 19 Aug 2026. 14 are still ongoing. 8 were reported in the last 12 months.

Total recalls21since 2012

Last 12 months8reported

Class I00% of total

Ongoing14latest 19 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 2Apr 0 3 0Jul 0 0 0Oct 0 1 0Jan '26 1 0 2Apr 2 0 0Jul 2 0

Severity split

Class I 0 0%Class II 20 95%Class III 1 5%

Why straumann usa is recalled

Product types

By year

2026733%
2025629%
2022210%
2021210%
201515%
2014210%
201215%

Ongoing straumann usa recalls

14 active

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	Straumann Bone Level Tapered (BLT) Implant, D RC, SLActive recalled	Straumann USA	Other	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states
1 Apr 2026Device	CLASS II	Custom Abutment AS Ti, for Straumann RC, incl recalled	Straumann USA	Packaging Defects	Nationwide
1 Apr 2026Device	CLASS II	Custom Abutment Ti, for Straumann RC, incl recalled	Straumann USA	Packaging Defects	Nationwide

All straumann usa recalls, newest first

21 total

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	Straumann Bone Level Tapered (BLT) Implant, D RC, SLActive recalled	Straumann USA	Other	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states
1 Apr 2026Device	CLASS II	Custom Abutment AS Ti, for Straumann RC, incl recalled	Straumann USA	Packaging Defects	Nationwide
1 Apr 2026Device	CLASS II	Custom Abutment Ti, for Straumann RC, incl recalled	Straumann USA	Packaging Defects	Nationwide
18 Feb 2026Device	CLASS III	WB Impression Post Closed Tray incl recalled by Straumann USA	Straumann USA	Packaging Defects	Nationwide
3 Dec 2025Device	CLASS II	Emdogain; Article Numbers: 440.230V10, 475.132V10 recalled	Straumann USA	Other	Nationwide
4 Jun 2025Device	CLASS II	GM Helix Acqua Implant, Article Number recalled by Straumann USA	Straumann USA	Packaging Defects	Nationwide
4 Jun 2025Device	CLASS II	Plus Initial Drill, Article Number recalled by Straumann USA	Straumann USA	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.