Drugs & medicalClass II

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…

Read the official notice →
Date
2026-08-19
Country
United States
Brand
Straumann
Product
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Classification
Class II
Units
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Straumann recalls

  1. 2026-09-23
  2. US
    Drugs & medicalClass II

    Straumann 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 →
  3. 2026-08-19
  4. US
    Drugs & medicalClass II

    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.

    FDA · DeviceStraumann USA LLCUS Nationwide distribution.Official notice →
  5. 2026-05-06
  6. US
    Drugs & medicalClass II

    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.

    FDA · DeviceStraumann USA LLCUS distribution to AL, AZ, FL, HI, LA, MD, OH, VA.Official notice →
  7. 2026-04-01
  8. US
    Drugs & medicalClass II

    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 →
  9. 2026-02-18
  10. US
    Drugs & medicalClass III

    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.

    FDA · DeviceStraumann USA LLCUS Nationwide distribution.Official notice →
  11. 2025-12-03
  12. US
    Drugs & medicalClass II

    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 →
All 12 Straumann recalls →

Other drugs & medical recalls in the United States

  1. 2026-08-19
  2. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version…

    Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224,…

    Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.WorldwideOfficial notice →
  4. US
    Drugs & medicalClass II

    Terumo Medical Corporation recalls GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate…

    Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

    FDA · DeviceTerumo Medical CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice →
  5. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional…

    Firmware issue potentially leading to loss of geometry movements.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Canada, Algeria,…Official notice →
  6. US
    Drugs & medicalClass II

    Remel Europe Ltd. recalls Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

    Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

    FDA · DeviceRemel Europe Ltd.US Nationwide distribution.Official notice →
  7. US
    Drugs & medicalClass II

    Medline Industries, LP recalls Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4

    Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may…

    FDA · DeviceMedline Industries, LPUS Nationwide distribution in the states and territories of Guam, Puerto Rico.Official notice →
See all drugs & medical recalls →