Drugs & medicalClass II

Straumann USA LLC recalls Plus Initial Drill, Article Number: 103.170;

The referred batch was produced without the laser engraving of 7 mm.

Read the official notice →
Date
2025-06-04
Country
United States
Brand
Straumann
Product
Plus Initial Drill, Article Number: 103.170;
Classification
Class II
Units
Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2026-02-18
  2. 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 →
  3. 2025-12-03
  4. 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 →
  5. 2025-06-04
  6. US
    Drugs & medicalClass II

    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 →
  7. 2025-04-30
  8. US
    Drugs & medicalClass II

    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 →
  9. 2025-04-23
  10. US
    Drugs & medicalClass II

    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 →
  11. 2022-01-26
  12. US
    Drugs & medicalClass II

    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 →
All 12 Straumann recalls →

Other drugs & medical recalls in the United States

  1. 2025-06-04
  2. US
    Drugs & medicalClass II

    Cardinal Health 200, LLC recalls Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs

    Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

    FDA · DeviceCardinal Health 200, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
  3. US
    Drugs & medicalClass II

    NxStage Medical Inc recalls NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.

    Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior…

    FDA · DeviceNxStage Medical IncUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    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 →
  5. US
    Drugs & medicalClass II

    Pro-Med Instruments Gmbh recalls DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

    Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

    FDA · DevicePro-Med Instruments GmbhWorldwide - US Nationwide distribution in the states of CA, CO, KY, ID, IL,…Official notice →
  6. US
    Drugs & medicalClass II

    Ultra Clean Systems, Inc. recalls Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system

    During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.

    FDA · DeviceUltra Clean Systems, Inc.Worldwide - U.S. Nationwide distribution including in the states of AZ, CA,…Official notice →
  7. US
    Drugs & medicalClass II

    C-RAD POSITIONING AB recalls Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT…

    Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

    FDA · DeviceC-RAD POSITIONING ABWorldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA,…Official notice →
See all drugs & medical recalls →