Straumann USA LLC recalls
Every recall we track for Straumann USA LLC — 18 in all, from 2021–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Straumann USA LLC peaked in 2025 (6); 18 since 2017. 6% rated “stop using now”.
All FDA recall records for Straumann USA LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 3 | 0 | 4 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 5 | 0 | 6 |
| 2026 (to date) | 0 | 0 | 6 | 2 | 8 |
Most common reasons for Straumann USA LLC recalls
What to do if you have a recalled Straumann USA LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Straumann USA LLC recalls
14 shown- Lower riskMedical device
Straumann USA LLC recalls GM Helix Implant, REF: 109.984;
Straumann recalls GM Helix Implant REF: 109.984 due to packaging dimensions not matching the actual implant. Affected units may have incorrect size specifications.
StraumannAug 12, 2026 - Lower riskMedical device
Straumann USA LLC recalls Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant,
Straumann recalls certain Bone Level Tapered implants that may be 12mm instead of 14mm. This could cause improper fit and complications during dental surgery. Affected implants have specific model numbers and lot codes.
StraumannJul 16, 2026 - Lower riskMedical device
Straumann USA LLC recalls GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Straumann recalls GM Helix dental implants with possible packaging mismatch. Incorrect implants could cause bone compression during installation if bone volume is sufficient.
StraumannJul 13, 2026 - Lower riskMedical device
Straumann USA LLC recalls Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Straumann recalls specific dental implant abutments with an incorrect screw seat interface that could cause improper installation. Affected units include model 010.0158 with UDI codes starting with (01)07630031759764.
StraumannMar 27, 2026 - UnratedMedical device
Straumann USA LLC recalls Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Straumann recalls Custom Abutment Ti products (Catalog 027.4620) due to manufacturing error using incorrect material. Affected items may have safety risks.
StraumannMar 17, 2026 - Lower riskMedical device
Straumann USA LLC recalls WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Straumann recalls WB Impression Post Closed Tray with magenta impression caps (should be brown) to prevent confusion in dental impressions.
StraumannJan 6, 2026 - Stop using nowMedical device
Straumann USA LLC recalls Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Straumann recalls Emdogain (article numbers 440.230V10 and 475.132V10) due to risk of being used on patients instead of for demonstration purposes only.
StraumannOct 17, 2025 - Lower riskMedical device
Straumann USA LLC recalls GM Helix Acqua Implant, Article Number: 140.984
Straumann recalls GM Helix Acqua Implant (Article 140.984) due to possible 11.5mm vs 13mm implant mix-up in packaging. Affected units may cause improper fit if used in dental procedures.
StraumannMay 1, 2025 - Lower riskMedical device
Straumann USA LLC recalls WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Straumann recalls WB XL Anatomic Healing Abutment XC dental implants due to incorrect blister labeling. Affected units have specific lot numbers and expiration dates. Consumers should check their product details to determine if they are impacted.
StraumannApr 17, 2025 - Lower riskMedical device
Straumann USA LLC recalls Plus Initial Drill, Article Number: 103.170;
Straumann recalls Plus Initial Drill (Article 103.170) due to missing laser engraving of 7 mm. Affected units have specific identifiers; contact for remedy.
StraumannApr 14, 2025 - Lower riskMedical device
Straumann USA LLC recalls TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Straumann recalls TLX/TLC SP Guided Implant Drivers with missing laser depth markings. This could affect dental procedures. Contact for details.
StraumannMar 8, 2025 - Lower riskMedical device
Straumann USA LLC recalls Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Straumann recalls Neodent Easypack Helix GM Acqua 3.5x13mm implants that were mislabeled as 3.5x8mm. This mislabeling could lead to incorrect implant placement. Affected units have specific article numbers and lot codes.
StraumannNov 30, 2021 - Lower riskMedical device
Straumann USA LLC recalls KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as
Straumann recalls 32.5 oz KeyPrint Soft- resin bottles sold in the US with European labels. These resin bottles are used for dental appliances like mouthguards. The recall is due to incorrect labeling for the US market.
StraumannJun 25, 2021 - Use cautionMedical device
Straumann USA LLC recalls Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical
Straumann recalls dental screwdrivers with incorrect profile that may not fit screws, risking injury during dental procedures. Affected models include SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel (Article 046.4:01).
StraumannMay 27, 2021
Straumann USA LLC recall questions
How many recalls has Straumann USA LLC had?
18 recalls from Straumann USA LLC are on record with U.S. safety agencies, from 2021–2026.
What is the most recent Straumann USA LLC recall?
Straumann USA LLC recalls GM Helix Implant, REF: 109.984;, dated Aug 12, 2026. Every Straumann USA LLC recall is listed on this page, newest first.
Why are Straumann USA LLC products recalled?
The most common reasons on record: Includes an incorrect screw seat interface. (2).
What should I do if I have a recalled Straumann USA LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Straumann USA LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.