The Recall Desk

Manufacturer

Straumann USA, LLC

21 recalls in our database name Straumann USA, LLC as the manufacturing or recalling firm.

What the numbers show

Total
21
Critical
0
Severe
0
Most recent
2026-08-19

Of the 21 recalls from Straumann USA, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

  • ModerateFDA (Devices)·Z-2935-2026·2026-08-19

    Straumann BLT Dental Implant Recall Due to Incorrect Length Labeling

    Straumann USA LLC is recalling 175 units of BLT dental implants that may be 12mm instead of the labeled 14mm length.

    Product
    Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2929-2026·2026-08-19

    Straumann Recalls GM Helix Dental Implants Due to Labeling Mismatch

    Straumann USA LLC is recalling 417 GM Helix dental implants because the implant inside the packaging may not match the outer carton label, potentially causing installation issues.

    Product
    GM Helix Implant, Endosseous Dental Implant Article No. 109.984
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1995-2026·2026-05-06

    Straumann n!ce Zr HT Dental Implant Abutments Recalled for Incorrect Screw Seat

    Straumann USA LLC is recalling 6 units of Straumann n!ce Zr, HT endosseous dental implant abutments (Article 010.0158) due to an incorrect screw seat interface that could affect proper implant function.

    Product
    Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1994-2026·2026-05-06

    Straumann n!ce PMMA Dental Implant Abutments Recalled for Screw Seat Defect

    Straumann USA LLC is recalling Straumann n!ce PMMA Full-arch Restoration screw-retained bridge abutments (Article 010.0304) due to an incorrect screw seat interface. Five units were distributed to dental offices in eight states.

    Product
    Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1632-2026·2026-04-01

    Straumann custom abutments made from wrong bar material after mix-up

    Straumann is recalling Custom Abutment Ti for Straumann RC because a material mix-up meant titanium abutments were manufactured from TAN bar material instead of Titanium Grade 4.

    Product
    Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1633-2026·2026-04-01

    Straumann angled custom abutments made from wrong bar material

    Straumann is recalling Custom Abutment AS Ti for Straumann RC because a material mix-up meant titanium abutments were manufactured from TAN bar material instead of Titanium Grade 4.

    Product
    Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1337-2026·2026-02-18

    Dental impression posts recalled over caps in the wrong colour

    Straumann USA is recalling 561 WB Impression Post Closed Tray units because the impression caps provided in the package are magenta instead of brown.

    Product
    WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2026·2025-12-03

    Demonstration only gel recalled because it may be placed in patients

    Straumann USA is recalling 61 units of Emdogain because product intended for demonstration purposes only could be placed in patients.

    Product
    Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2025·2025-06-04

    GM Helix Acqua Implant dental implant size misidentification recall

    Straumann USA LLC is recalling the GM Helix Acqua Implant (Article Number 140.985) because some packages labeled as 11.5 mm implants may contain 13 mm implants instead.

    Product
    GM Helix Acqua Implant, Article Number: 140.985
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1861-2025·2025-06-04

    Straumann Plus Initial Drill missing laser engraving marking

    Straumann USA LLC is recalling Plus Initial Drill units (Article Number 103.170, Lot LNWT8) because the batch was produced without the required 7 mm laser engraving marking.

    Product
    Plus Initial Drill, Article Number: 103.170;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1862-2025·2025-06-04

    GM Helix Acqua Implant labeled 11.5 mm may contain 13 mm

    Straumann USA LLC is recalling GM Helix Acqua Implants (Article Number 140.984) because packages labeled as 11.5 mm implants may contain 13 mm implants instead.

    Product
    GM Helix Acqua Implant, Article Number: 140.984
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1671-2025·2025-04-30

    Straumann WB XL Anatomic Healing Abutment XC Dental Implants

    Straumann USA LLC is recalling 1,786 units of WB XL Anatomic Healing Abutment XC endosseous dental implant abutments due to incorrect blister labeling. The product was distributed worldwide.

    Product
    WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2025·2025-04-23

    TLX/TLC SP Guided Implant Driver missing laser marked depth markings

    Straumann USA LLC is recalling TLX/TLC SP Guided Implant Driver units because they are missing laser marked depth markings, which may affect proper surgical placement.

    Product
    TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0512-2022·2022-01-26

    Dental Implant Mislabeling: Neodent Easypack Helix GM Acqua Dimension Error

    Straumann USA LLC recalls Neodent Easypack Helix GM Acqua dental implants due to mislabeling. Implants have incorrect dimensions compared to carton labels, which could affect surgical planning and placement.

    Product
    Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0513-2022·2022-01-26

    Dental implant kits recalled for mislabeled implant dimensions

    Straumann USA LLC is recalling certain Neodent Easypack dental implant kits due to mislabeling where packaging does not match the implant dimensions inside. Affected units contain 3.5x8mm implants instead of the labeled 3.5x13mm size.

    Product
    Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2336-2021·2021-09-01

    KeyPrint Soft Dental Resin Recalled for Incorrect European Labeling

    Straumann USA LLC recalled KeyPrint Soft resin bottles (Lot KJ2858) that were distributed with European product labels instead of US-compliant labeling. Dental professionals should verify if they received affected units.

    Product
    KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2021·2021-08-11

    Straumann SCS Screwdriver Recalled for Incorrect Tip Configuration

    Straumann USA LLC is recalling 130 units of the Straumann SCS Screwdriver (Article 046.401) due to an incorrect tip configuration that prevents proper engagement with screw heads during dental surgery, creating a potential injury risk.

    Product
    Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0981-2015·2015-01-21

    Straumann Dental Implant Drill Set Recalled for Incorrect Drill

    Straumann USA is recalling dental implant drill sets that may contain incorrect drills. The recall covers 362 pieces distributed nationwide and internationally.

    Product
    Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0174-2015·2014-11-12

    Straumann Dental Implant Recall Due to Incorrect Product Transfer Piece

    Straumann USA is recalling 111 units of Bone Level Implants because the product transfer piece was fitted with a Narrow Connect instead of a Regular Connect.

    Product
    Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2015·2014-10-29

    Straumann Dental Implant Recall Due to Incorrect Component Assembly

    Straumann USA is recalling 6 units of Bone Level Tapered Dental Implants because they were assembled with the wrong transfer piece.

    Product
    Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentu
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2161-2012·2012-08-15

    Straumann Dental Implant Screw Recall Due to Incorrect Component

    Straumann USA is recalling 14 dental implant sets because the included screw was not the correct Narrow CrossFit model.

    Product
    Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Straumann

company

Country
Switzerland
Founded
1954

Official website

Source: Wikidata (Q664481), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.