FDA Device Recalls

Recalls / Firms / Straumann USA LLC

Straumann USA LLC

21 FDA device recalls on record.

DateClassProductReason
2026-03-17—Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
2026-03-17—Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
2026-01-06—WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
2025-10-17—Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
2025-05-01—GM Helix Acqua Implant, Article Number: 140.984
2025-05-01—GM Helix Acqua Implant, Article Number: 140.985
2025-04-17—WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
2025-04-14—Plus Initial Drill, Article Number: 103.170;
2025-03-08—TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
2021-11-30—Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
2021-11-30—Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
2021-06-25—KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances
2021-05-27—Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.
2014-10-27—Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous
2014-09-24—Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Prod
2014-09-19—Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5
2012-07-11—Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Numb
2012-03-12—Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implant
2008-01-10—Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann,
2007-09-28—Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, M
2007-09-28—Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, M