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Straumann USA LLC FDA Recalls
18 recalls on file across devices, 0 of them Class I and 15 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| GM Helix Implant, REF: 109.984;Class IIAug 12, 2026There is a discrepancy between the product identification on |
| Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosClass IIJul 16, 2026Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, |
| GM Helix Implant, Endosseous Dental Implant Article No. 109.984Class IIJul 13, 2026There may be a mismatch between the implant contained inside |
| Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant AbutmentsClass IIMar 27, 2026Includes an incorrect screw seat interface. |
| Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant AbutmenClass IIMar 27, 2026Includes an incorrect screw seat interface. |
| Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;Class IIMar 17, 2026A material mix-up had occurred during the manufacturing of S |
| Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;Class IIMar 17, 2026A material mix-up had occurred during the manufacturing of S |
| WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POMClass IIIJan 6, 2026The mix up of the impression caps provided in the package. T |
| Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;Class IIOct 17, 2025The possibility for this product that is intended for demons |
| GM Helix Acqua Implant, Article Number: 140.984Class IIMay 1, 2025It is possible that a package labelled as an 11.5 mm implant |
| GM Helix Acqua Implant, Article Number: 140.985Class IIMay 1, 2025It is possible that a package labelled as an 11.5 mm implant |
| WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.Class IIApr 17, 2025Incorrect blister labelling. |
| Plus Initial Drill, Article Number: 103.170;Class IIApr 14, 2025The referred batch was produced without the laser engraving |
| TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;Class IIMar 8, 2025The devices are missing the laser marked depth markings. |
| Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107Class IINov 30, 2021Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua |
| Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089Class IINov 30, 2021Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua |
| KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguardsClass IIJun 25, 2021Product label intended for the European community was distri |
| Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgicaClass IIMay 27, 2021Tip of the screwdriver does not have the correct configurati |