Straumann USA LLC
Complete recall history across all FDA and CPSC categories — 13 total recalls
Straumann USA LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (13)
FDA medical device enforcement actions by Straumann USA LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 17, 2026 | Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art... | A material mix-up had occurred during the manufacturing of Straumann¿ Custom ... | Class II |
| Mar 17, 2026 | Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: ... | A material mix-up had occurred during the manufacturing of Straumann¿ Custom ... | Class II |
| Jan 6, 2026 | 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 impre... | Class III |
| Oct 17, 2025 | Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; | The possibility for this product that is intended for demonstration purposes ... | Class II |
| May 1, 2025 | GM Helix Acqua Implant, Article Number: 140.985 | It is possible that a package labelled as an 11.5 mm implant may contain a 13... | Class II |
| May 1, 2025 | 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... | Class II |
| Apr 17, 2025 | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | Incorrect blister labelling. | Class II |
| Apr 14, 2025 | Plus Initial Drill, Article Number: 103.170; | The referred batch was produced without the laser engraving of 7 mm. | Class II |
| Mar 8, 2025 | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; | The devices are missing the laser marked depth markings. | Class II |
| Nov 30, 2021 | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental impl... | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X... | Class II |
| Nov 30, 2021 | 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 4.5X... | Class II |
| Jun 25, 2021 | KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodonti... | Product label intended for the European community was distributed to the USA ... | Class II |
| May 27, 2021 | Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless stee... | Tip of the screwdriver does not have the correct configuration / profile ther... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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