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Orthofix US LLC

United Statesfrom the FDA registration address FDA FEI 2183449

Orthofix US LLC is a medical device manufacturer, with 9,794 devices listed and 13 FDA recalls as of 12 Nov 2026.

Devices
9,794
Registrations
FDA
FDA recalls
1313 ongoing

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 3,000

Among the 3,000 best-ranked of 9,794 devices.

Device classes
  • FDA Class II 1,930
  • FDA Class I 1,070

Among the 3,000 best-ranked of 9,794 devices.

FDA recalls
Identifiers
  • FDA FEI 2183449
  • DUNS 927083808

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What Orthofix US LLC makes

Orthofix US LLC manufactures metallic spinal interbody fusion cages, spinal fixation plates (non-bioabsorbable), and bone-screw internal fixation systems for spinal stabilization, including non-sterile variants. Their portfolio also includes growth-correction orthopaedic fixation plates, vertebral body prostheses (non-sterile), and sacroiliac joint fixation implants. Reusable manual surgical rotary handpieces are part of their surgical tooling offerings.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database.

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

Catalogue9,794

Newest first, rows 1-50 of 9,794

Search and filter all 9,794 devices
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  • Pillar SA 49-0093

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Firebird Sfs 51-0070

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Firebird Sfs 51-0570

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Firebird Sfs, Special Products 52-1002

    Listed Registry: GUDID Class:I

  • Proview 54-1001

    Listed Registry: GUDID Class:I

  • Removal Instruments 54-1035

    Listed Registry: GUDID Class:I

  • Removal Instruments 54-1036

    Listed Registry: GUDID Class:I

  • Proview 54-1050

    Listed Registry: GUDID Class:I

  • Proview 54-1062

    Listed Registry: GUDID Class:I

  • Removal Instruments 54-1063

    Listed Registry: GUDID Class:I

  • Sfs 55-1090

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Sfs 55-2060

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2070

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2080

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2090

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2110

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2111

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2112

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2114

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2116

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2118

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2120

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sfs 55-2145

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Cetra, Janus, Lonestar 69-1030

    Listed Registry: GUDID Class:I

  • Proview 70-4091

    Listed Registry: GUDID Class:I

  • Proview 70-4103

    Listed Registry: GUDID Class:I

  • Ngage 74-0093

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Ngage 74-0092

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Cetra 86-9010

    Listed Registry: GUDID Class:I

  • Cetra 86-9018

    Listed Registry: GUDID Class:I

  • Cetra 86-9020

    Listed Registry: GUDID Class:I

  • Cetra 86-9024

    Listed Registry: GUDID Class:I

  • Cetra 86-9026

    Listed Registry: GUDID Class:I

  • Cetra 86-9028

    Listed Registry: GUDID Class:I

  • Removal Instruments 86-9070

    Listed Registry: GUDID Class:I

  • Forza 89-0103

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Forza 89-0102

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Forza 89-0104

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Forza 89-0105

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Forza 89-0106

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Forza 89-0107

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Forza 89-0115

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Forza 89-0118

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Phoenix Sfs 20-1000

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Alloquent - Alif 32-1061

    Listed Registry: GUDID Class:I

  • Alloquent - Alif 32-1060

    Listed Registry: GUDID Class:I

  • Centurion 69-8124

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Alloquent - Alif 32-1062

    Listed Registry: GUDID Class:I

  • Alloquent - Alif 32-1064

    Listed Registry: GUDID Class:I

  • Alloquent - Alif 32-1063

    Listed Registry: GUDID Class:I

Rows 1-50 of 9,794

Showing 1-50 of 9,794

Company details

FDA FEI number
2183449
DUNS number
927083808
Address
3451 Plano Parkway, Lewisville, TX, 75056
Phone
+1(800)527-0404

FDA recalls13

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 13 recalls initiated by Orthofix US LLC, the earliest on 2025-02-20 and the most recent on 2026-06-10. By recorded status: 13 ongoing. The reasons filed fall into these groups: labeling or instructions for use and performance or accuracy. 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 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 9
  • 2026 4

Showing the 10 most recent of 13 recalls.

  • 2026

    • 10 Jun 2026 Z-2729-2026 Class II Ongoing Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None Submission number: K113770
    • 10 Jun 2026 Z-2730-2026 Class II Ongoing Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None Submission number: K113770
    • 10 Jun 2026 Z-2731-2026 Class II Ongoing Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None Submission number: K113770
    • 10 Jun 2026 Z-2732-2026 Class II Ongoing Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None Submission number: K113770

  • 2025

    • 3 Nov 2025 Z-0891-2026 Class III Ongoing Labeling contains claims that are not consistently present. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.
      Submission number: K172437
    • 3 Nov 2025 Z-0892-2026 Class III Ongoing Labeling contains claims that are not consistently present. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.
      Submission number: K172437
    • 3 Nov 2025 Z-0893-2026 Class III Ongoing Labeling contains claims that are not consistently present. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.
      Submission number: K172437
    • 3 Nov 2025 Z-0894-2026 Class III Ongoing Labeling contains claims that are not consistently present. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.
      Submission number: K200696
    • 3 Nov 2025 Z-0895-2026 Class III Ongoing Labeling contains claims that are not consistently present. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.
      Submission number: K203576
    • 3 Nov 2025 Z-0896-2026 Class III Ongoing Labeling contains claims that are not consistently present. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.
      Submission number: K203342
Show all 13 recalls

  • 2025

    • 19 Sep 2025 Z-0478-2026 Class II Ongoing Polyaxial screws do not meet performance standards. Distribution: US Nationwide distribution in the states of California, North Carolina, and Texas. Submission number: K250908
    • 24 Jun 2025 Z-2555-2025 Class II Ongoing A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct. Distribution: US Nationwide distribution in the states of CO, CA. Submission number: K240749
    • 20 Feb 2025 Z-1432-2025 Class II Ongoing The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm. Distribution: US Nationwide distribution in the states of California, Colorado, and Missouri. Submission number: K240749

Frequently asked questions

How many devices does Orthofix US LLC have in the registry?

The registry currently lists 9794 devices for Orthofix US LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Orthofix US LLC's devices?

Among its 50 most recently registered devices, Orthofix US LLC has devices listed in FDA GUDID (50 devices).

What risk classes do Orthofix US LLC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Orthofix US LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Orthofix US LLC?

FDA recall records list 13 recalls initiated by Orthofix US LLC, the most recent initiated on 10 Jun 2026. 13 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Orthofix US LLC in the registry?

The most recently registered devices listed for Orthofix US LLC include PILLAR SA 49-0093, FIREBIRD SFS 51-0070, FIREBIRD SFS 51-0570 and FIREBIRD SFS, SPECIAL PRODUCTS 52-1002.

Generated automatically from registry data and not verified by a human reviewer.