FDA recall record · openFDA

Straumann USA LLC

11 FDA recalls on record (2025–2026) — 11 device. 11 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Includes an incorrect screw seat interface. 2

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw materia 2

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. 2

The possibility for this product that is intended for demonstration purposes only to be placed in patients. 1

The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. 1

Recalls

Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments Class II 2026-03-27 Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutmen Class II 2026-03-27 Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; Class II 2026-03-17 Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438; Class II 2026-03-17 Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; Class II 2025-10-17 TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; Class II 2025-03-08 GM Helix Acqua Implant, Article Number: 140.984 Class II 2025-05-01 Plus Initial Drill, Article Number: 103.170; Class II 2025-04-14 GM Helix Acqua Implant, Article Number: 140.985 Class II 2025-05-01 WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. Class II 2025-04-17 WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM Class III 2026-01-06

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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