Straumann USA recalls

Straumann USA has 22 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 23 Sep 2026. 15 are still ongoing. 9 were reported in the last 12 months.

Total recalls22since 2012

Last 12 months9reported

Class I00% of total

Ongoing15latest 23 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 2 0May 3 0 0Aug 0 0 0Nov 1 0 1Feb 0 2 2May 0 0 2Aug 1 0

Severity split

Class I 0 0%Class II 21 95%Class III 1 5%

Why straumann usa is recalled

Product types

By year

2026836%
2025627%
202229%
202129%
201515%
201429%
201215%

Ongoing straumann usa recalls

15 active

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	GM Helix Implant recalled by Straumann USA	Straumann USA	Packaging Defects	Nationwide
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

All straumann usa recalls, newest first

22 total

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	GM Helix Implant recalled by Straumann USA	Straumann USA	Packaging Defects	Nationwide
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
4 Jun 2025Device	CLASS II	GM Helix Acqua Implant, Article Number recalled by Straumann USA	Straumann USA	Packaging Defects	Nationwide
30 Apr 2025Device	CLASS II	WB XL Anatomic Healing Abutment XC. Endosseous Dental recalled	Straumann USA	Other	Nationwide
23 Apr 2025Device	CLASS II	TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel recalled	Straumann USA	Foreign Material	Nationwide
26 Jan 2022Device	CLASS II	Neodent Easypack Helix GM Acqua 3./Smart 4..5 -intended recalled	Straumann USA	Labeling Errors	Nationwide
26 Jan 2022Device	CLASS II	Neodent Easypack Helix GM Acqua 3./Smart 4..5 Article recalled	Straumann USA	Labeling Errors	Nationwide
1 Sep 2021Device	CLASS II	KeyPrint Soft recalled by Straumann USA	Straumann USA	Other	Nationwide
11 Aug 2021Device	CLASS II	Straumann SCS Screwdriver, driver, for ratchet, short, L recalled	Straumann USA	Device Malfunction	Nationwide
21 Jan 2015Device	CLASS II	Drill set long, drill stop compatible for diameter implant recalled	Straumann USA	Other	Nationwide
12 Nov 2014Device	CLASS II	Straumann Bone Level Implant RC, SLActive¿, Roxolid¿ recalled	Straumann USA	Potency & Assay	Nationwide
29 Oct 2014Device	CLASS II	Straumann Bone Level Tapered Implant RC, SLActive¿ recalled	Straumann USA	Other	FL, MA
15 Aug 2012Device	CLASS II	Straumann Narrow CrossFit (NC) Screw for Cares Abutment ZrO2 recalled	Straumann USA	Potency & Assay	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.