Straumann USA Recalls
21 recalls on record · August 15, 2012 to August 19, 2026 · Medical Devices
Recalls by year
12
14
15
21
22
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 19, 2026Medical DevicesFDA
Straumann USA LLC recalls Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endos
Hazard: Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
August 19, 2026Medical DevicesFDA
Straumann USA LLC recalls GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Hazard: There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
May 6, 2026Medical DevicesFDA
Straumann USA LLC recalls Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Hazard: Includes an incorrect screw seat interface.
May 6, 2026Medical DevicesFDA
Straumann USA LLC recalls Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutmen
Hazard: Includes an incorrect screw seat interface.
April 1, 2026Medical DevicesFDA
Straumann USA LLC recalls Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Hazard: A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
April 1, 2026Medical DevicesFDA
Straumann USA LLC recalls Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Hazard: A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
February 18, 2026Medical DevicesFDA
Straumann USA LLC recalls WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Hazard: The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
December 3, 2025Medical DevicesFDA
Straumann USA LLC recalls Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Hazard: The possibility for this product that is intended for demonstration purposes only to be placed in patients.
June 4, 2025Medical DevicesFDA
Straumann USA LLC recalls GM Helix Acqua Implant, Article Number: 140.985
Hazard: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
June 4, 2025Medical DevicesFDA
Straumann USA LLC recalls GM Helix Acqua Implant, Article Number: 140.984
Hazard: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
June 4, 2025Medical DevicesFDA
Straumann USA LLC recalls Plus Initial Drill, Article Number: 103.170;
Hazard: The referred batch was produced without the laser engraving of 7 mm.
April 30, 2025Medical DevicesFDA
Straumann USA LLC recalls WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Hazard: Incorrect blister labelling.
April 23, 2025Medical DevicesFDA
Straumann USA LLC recalls TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Hazard: The devices are missing the laser marked depth markings.
January 26, 2022Medical DevicesFDA
Straumann USA LLC recalls Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Hazard: Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
January 26, 2022Medical DevicesFDA
Straumann USA LLC recalls Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Hazard: Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
September 1, 2021Medical DevicesFDA
Straumann USA LLC recalls KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards
Hazard: Product label intended for the European community was distributed to the USA market via their US distribution organization
August 11, 2021Medical DevicesFDA
Straumann USA LLC recalls Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgica
Hazard: Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury
January 21, 2015Medical DevicesFDA
Straumann USA, LLC recalls Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant dril
Hazard: Drill set may contain incorrect drill.
November 12, 2014Medical DevicesFDA
Straumann USA, LLC recalls Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Den
Hazard: Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
October 29, 2014Medical DevicesFDA
Straumann USA, LLC recalls Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental imp
Hazard: Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
August 15, 2012Medical DevicesFDA
Straumann USA, LLC recalls Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Pro
Hazard: Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2