Straumann recalls
12 official recalls and safety alerts involving Straumann since 2022-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Straumann or the relevant agency.
- 2026-09-23
USStraumann USA LLC recalls GM Helix Implant, REF: 109.984;
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
FDA · DeviceStraumann USA LLCUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS,…Official notice →- 2026-08-19
- US
Straumann USA LLC recalls Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
- US
Straumann USA LLC recalls GM Helix Implant, Endosseous Dental Implant Article No. 109.984
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or…
FDA · DeviceStraumann USA LLCUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - 2026-05-06
- US
Straumann USA LLC recalls Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Includes an incorrect screw seat interface.
- 2026-04-01
- US
Straumann USA LLC recalls Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti…
FDA · DeviceStraumann USA LLCWorldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL,…Official notice → - 2026-02-18
- US
Straumann USA LLC recalls WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
- 2025-12-03
- US
Straumann USA LLC recalls Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
FDA · DeviceStraumann USA LLCUS Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX,…Official notice → - 2025-06-04
- US
Straumann USA LLC recalls GM Helix Acqua Implant, Article Number: 140.984
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
FDA · DeviceStraumann USA LLCWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il…Official notice → - US
Straumann USA LLC recalls Plus Initial Drill, Article Number: 103.170;
The referred batch was produced without the laser engraving of 7 mm.
FDA · DeviceStraumann USA LLCWorldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL,…Official notice → - 2025-04-30
- US
Straumann USA LLC recalls WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Incorrect blister labelling.
FDA · DeviceStraumann USA LLCWorldwide distribution - US Nationwide and the countries of Belgium, Canada,…Official notice → - 2025-04-23
- US
Straumann USA LLC recalls TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
The devices are missing the laser marked depth markings.
FDA · DeviceStraumann USA LLCWorldwide - US Nationwide distribution in the states of CA, IN, ME, MN and the…Official notice → - 2022-01-26
- US
Straumann USA LLC recalls Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
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…
FDA · DeviceStraumann USA LLCUS Nationwide Distribution in the states of FL, IL, OHOfficial notice →