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Straumann USA

Also registered as Straumann USA, Inc., Straumann USA, LLC

United Statesfrom the FDA registration address FDA FEI 1000121052

Devices
66
Registrations
FDA
FDA recalls
2615 ongoing

What Straumann USA makes

Straumann USA manufactures a range of dental and orthopedic implant products, including endosseous and extraoral dental implants of various diameters, screw‑retained bridge titanium components, prosthetic accessories such as implant copings and abutments, angled and temporary abutments, bonding bases, guided surgical instruments, and a computer‑aided restoration service, as well as specific orthodontic implant accessories and SynOcta prosthetic solutions.

These devices are classified as Class I, Class II, or U and are listed in the FDA 510(k) database. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue66

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Company details

FDA FEI number
1000121052
Address
60 MINUTEMAN RD., ANDOVER, MA, 01810

FDA recalls26

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 26 recalls initiated by Straumann USA, the earliest on 2007-09-28 and the most recent on 2026-08-12. By recorded status: 15 ongoing and 11 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 4
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 6
  • 2026 8

8 initiated before 2017

Showing the 10 most recent of 26 recalls.

  • 2026

    • 12 Aug 2026 Z-3173-2026 Class II Ongoing 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,…
      Full distribution text 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;
      Submission number: K163194
    • 16 Jul 2026 Z-2935-2026 Class II Ongoing 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. Submission number: K140878
    • 13 Jul 2026 Z-2929-2026 Class II Ongoing 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,…
      Full distribution text 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.
      Submission number: K163194
    • 27 Mar 2026 Z-1994-2026 Class II Ongoing Includes an incorrect screw seat interface. Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA. Submission number: K242686
    • 27 Mar 2026 Z-1995-2026 Class II Ongoing Includes an incorrect screw seat interface. Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA. Submission number: K222836
    • 17 Mar 2026 Z-1632-2026 Class II Ongoing 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…
      Full distribution text Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.
      Submission number: K072151
    • 17 Mar 2026 Z-1633-2026 Class II Ongoing 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…
      Full distribution text Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.
      Submission number: K243278
    • 6 Jan 2026 Z-1337-2026 Class III Ongoing The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. Distribution: US Nationwide distribution.

  • 2025

    • 17 Oct 2025 Z-0582-2026 Class II Ongoing 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. Submission number: P930021
    • 1 May 2025 Z-1862-2025 Class II Ongoing 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,…
      Full distribution text 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, United Kingdom, Vietnam.
      Submission number: K163194
Show the 25 most recent of 26 recalls

  • 2025

    • 1 May 2025 Z-1863-2025 Class II Ongoing 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,…
      Full distribution text 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, United Kingdom, Vietnam.
      Submission number: K163194
    • 17 Apr 2025 Z-1671-2025 Class II Ongoing Incorrect blister labelling. Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden. Submission number: K241575
    • 14 Apr 2025 Z-1861-2025 Class II Ongoing 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…
      Full distribution text 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.
    • 8 Mar 2025 Z-1561-2025 Class II Ongoing 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,…
      Full distribution text 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.

  • 2021

    • 30 Nov 2021 Z-0512-2022 Class II Terminated 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 Submission number: K203382
    • 30 Nov 2021 Z-0513-2022 Class II Terminated 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 Submission number: K203382
    • 25 Jun 2021 Z-2336-2021 Class II Ongoing 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. Submission number: K183598
    • 27 May 2021 Z-2198-2021 Class II Terminated 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

  • 2014

    • 27 Oct 2014 Z-0981-2015 Class II Terminated Drill set may contain incorrect drill. Distribution: Nationwide in the following states: AZ, CA, CO,CT, FL, IA, IL, IN, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OH, OK, OR, PA,…
      Full distribution text Nationwide in the following states: AZ, CA, CO,CT, FL, IA, IL, IN, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, VA and WV. Worldwide in the following countries by Institut Straumann AG distribution network: Austria, Australia, Canada, Germany, Spain, Finland, France, United Kingdom, Netherlands, Belgium, Switzerland, Ireland, Italy.
    • 24 Sep 2014 Z-0174-2015 Class II Terminated Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) Distribution: US Nationwide Distribution Submission number: K121131
    • 19 Sep 2014 Z-0117-2015 Class II Terminated Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) Distribution: US Distribution in states of: FL and MA. Submission number: K140878

  • 2012

    • 11 Jul 2012 Z-2161-2012 Class II Terminated Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2 Distribution: US Nationwide Distribution including the countries of FL, IN, LA, NY and TX. Submission number: K081005
    • 12 Mar 2012 Z-1351-2012 Not yet classified Terminated Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN Distribution: Nationwide Distribution. Submission number: K033922

  • 2008

    • 10 Jan 2008 Z-1037-2008 Unclassified (pre-2012) Terminated Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection. Distribution: Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX. Submission number: K071585

  • 2007

    • 28 Sep 2007 Z-0277-2008 Unclassified (pre-2012) Terminated Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force. Distribution: Nationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA,…
      Full distribution text Nationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA, and WA.
      Submission number: K060062