Andover, MA, United States
Straumann USA LLC recalls
14 recalls recorded since 2018, most recently on 12 August 2026. 12 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)12
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 12 August 2026
- Reason
- There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3173-2026
- GM Helix Implant, REF: 109.984;
Ongoing Class II Medical devices
- Recall started
- 16 July 2026
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2935-2026
- Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Ongoing Class II Medical devices
- Recall started
- 13 July 2026
- Reason
- 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
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2929-2026
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Ongoing Class II Medical devices
- Recall started
- 27 March 2026
- Reason
- Includes an incorrect screw seat interface.
- Distribution
- US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1995-2026, Z-1994-2026
- Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
- Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Ongoing Class II Medical devices
- Recall started
- 17 March 2026
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1632-2026, Z-1633-2026
- Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
- Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Ongoing Class III Medical devices
- Recall started
- 6 January 2026
- Reason
- The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1337-2026
- WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Ongoing Class II Medical devices
- Recall started
- 17 October 2025
- Reason
- The possibility for this product that is intended for demonstration purposes only to be placed in patients.
- Distribution
- US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0582-2026
- Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Ongoing Class II Medical devices
- Recall started
- 1 May 2025
- Reason
- It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, Uni
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1862-2025, Z-1863-2025
- GM Helix Acqua Implant, Article Number: 140.984
- GM Helix Acqua Implant, Article Number: 140.985
Ongoing Class II Medical devices
- Recall started
- 17 April 2025
- Reason
- Incorrect blister labelling.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1671-2025
- WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Ongoing Class II Medical devices
- Recall started
- 14 April 2025
- Reason
- The referred batch was produced without the laser engraving of 7 mm.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MN, NC, NV, NY, OH, OK, SC, TX, VA, WI and the countries of Brazil, Germany, India, Indonesia, Portugal, Romania, Spain, Switzerland, Ukraine.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1861-2025
- Plus Initial Drill, Article Number: 103.170;
Ongoing Class II Medical devices
- Recall started
- 8 March 2025
- Reason
- The devices are missing the laser marked depth markings.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, IN, ME, MN and the countries of Belgium, Finland, France, Germany, Iceland, Israel, Italy, Latvia, Malta, Romania, Switzerland, Ukraine, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1561-2025
- TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Terminated Class II Medical devices
- Recall started
- 30 November 2021
- Terminated
- 5 February 2025
- Reason
- 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
- Distribution
- US Nationwide Distribution in the states of FL, IL, OH
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0513-2022, Z-0512-2022
- Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
- Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Ongoing Class II Medical devices
- Recall started
- 25 June 2021
- Reason
- Product label intended for the European community was distributed to the USA market via their US distribution organization
- Distribution
- US Nationwide distribution in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2336-2021
- KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
Terminated Class II Medical devices
- Recall started
- 27 May 2021
- Terminated
- 21 March 2023
- Reason
- 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
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2198-2021
- Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.