Skip to content

Stryker Spine

United Statesfrom the FDA registration address FDA FEI 3004024955

Devices
73
Registrations
FDA
FDA recalls
996 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment, FDA recalls

What Stryker Spine makes

Stryker Spine manufactures spinal fixation systems, including pedicle screw-based constructs like the XIA 4.5, XIA 3, and Radius systems, as well as vertebral body replacement solutions such as the VLIFT and VLIFT-s systems. Their portfolio also includes modular spinal systems like the Mantis and Trio series, augmentable spinal implants, and occipito-cervico-thoracic fixation devices. Additional offerings include interbody fusion spacers, such as the Ascential IBD PEEKc Spacer, and modifications to existing systems for tailored surgical applications.

These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearances or PMA submissions. The company’s products are listed in the FDA’s regulatory databases for spinal implants and fixation hardware. Stryker Spine operates as a subsidiary based in the United States.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue73

Newest first, rows 1-50 of 73

Search and filter all 73 devices
Skip device list

Rows 1-50 of 73

Showing 1-50 of 73

Company details

FDA FEI number
3004024955
Address
2 PEARL COURT, ALLENDALE, NJ, 07401

FDA recalls99

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

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 0
  • 2020 0
  • 2021 3
  • 2022 0
  • 2023 1
  • 2024 1
  • 2025 4
  • 2026 0

89 initiated before 2017

Showing the 10 most recent of 99 recalls.

  • 2025

    • 28 Feb 2025 Z-1488-2025 Class II Ongoing Potential for the gold unlock button to separate from the inserter.via FDA establishment STRYKER SPINE Distribution: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada. Submission number: K201585
    • 28 Feb 2025 Z-1489-2025 Class II Ongoing Potential for the gold unlock button to separate from the inserter.via FDA establishment STRYKER SPINE Distribution: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada. Submission number: K201585
    • 28 Feb 2025 Z-1490-2025 Class II Ongoing Potential for the gold unlock button to separate from the inserter.via FDA establishment STRYKER SPINE Distribution: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada. Submission number: K201585
    • 28 Feb 2025 Z-1491-2025 Class II Ongoing Potential for the gold unlock button to separate from the inserter.via FDA establishment STRYKER SPINE Distribution: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada. Submission number: K201585

  • 2024

    • 23 Aug 2024 Z-3210-2024 Class II Ongoing Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.via FDA establishment STRYKER SPINE Distribution: Worldwide distribution - US Nationwide and the country of Canada. Submission number: K102606

  • 2023

    • 1 Nov 2023 Z-0610-2024 Class II Ongoing Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.via FDA establishment STRYKER SPINE Distribution: US: MD, MI, NM, TX & OUS: Canada & France.

  • 2021

    • 18 May 2021 Z-2100-2021 Class II Terminated The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.via FDA establishment STRYKER SPINE Distribution: US Nationwide Distribution Submission number: K080108
    • 18 May 2021 Z-2101-2021 Class II Terminated The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.via FDA establishment STRYKER SPINE Distribution: US Nationwide Distribution Submission number: K080108
    • 11 Mar 2021 Z-1437-2021 Class II Terminated Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.via FDA establishment STRYKER SPINE Distribution: US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.

  • 2018

    • 13 Aug 2018 Z-0092-2019 Class II Terminated The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.via FDA establishment STRYKER SPINE Distribution: US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR Submission number: K151726
Show the 25 most recent of 99 recalls

  • 2015

    • 18 Dec 2015 Z-0828-2016 Class II Terminated Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.via FDA establishment STRYKER SPINE Distribution: Nationwide Distribution
    • 16 Dec 2015 Z-0852-2016 Class II Terminated There were two potential interference conditions identified with the way the tubing set attaches to the inserter.via FDA establishment STRYKER SPINE Distribution: US Nationwide Distribution Submission number: K143616
    • 25 Sep 2015 Z-0270-2016 Class II Terminated Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device.via FDA establishment STRYKER SPINE Distribution: Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO,…
      Full distribution text Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NM, NY, OH, OK, OR, PA, TN, TX, UT, WA and WI.
    • 8 Sep 2015 Z-0222-2016 Class II Terminated The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.via FDA establishment STRYKER SPINE Distribution: Nationwide Distribution.

  • 2014

    • 6 Oct 2014 Z-0803-2015 Class II Terminated Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.via FDA establishment STRYKER SPINE Distribution: Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.
    • 7 Jul 2014 Z-2626-2014 Class II Terminated Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.via FDA establishment STRYKER SPINE Distribution: Worldwide Distribution - USA including OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK,…
      Full distribution text Worldwide Distribution - USA including OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK, MT, FL, AL, CO, TN, and WI and Internationally to Australia.
    • 7 Jul 2014 Z-2627-2014 Class II Terminated Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.via FDA establishment STRYKER SPINE Distribution: Worldwide Distribution - USA including OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK,…
      Full distribution text Worldwide Distribution - USA including OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK, MT, FL, AL, CO, TN, and WI and Internationally to Australia.

  • 2013

    • 18 Dec 2013 Z-1086-2014 Class II Terminated Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.via FDA establishment STRYKER SPINE Distribution: US Nationwide Distribution
    • 24 Sep 2013 Z-0375-2014 Class II Terminated Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.via FDA establishment STRYKER SPINE Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada,…
      Full distribution text Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Iraq, Egypt, and Turkey.
    • 30 May 2013 Z-1976-2013 Class I Terminated Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.via FDA establishment STRYKER SPINE Distribution: Nationwide Distribution. Submission number: K093670

  • 2012

    • 27 Dec 2012 Z-0893-2013 Class II Terminated Surgeons have experienced unthreading of the screwdrivers outer shafts during use.via FDA establishment STRYKER SPINE Distribution: Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY.…
      Full distribution text Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI.
    • 9 Aug 2012 Z-0380-2013 Class II Terminated Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.via FDA establishment STRYKER SPINE Distribution: Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan,…
      Full distribution text Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
    • 9 Aug 2012 Z-0381-2013 Class II Terminated Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.via FDA establishment STRYKER SPINE Distribution: Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan,…
      Full distribution text Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
    • 9 Aug 2012 Z-0382-2013 Class II Terminated Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.via FDA establishment STRYKER SPINE Distribution: Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan,…
      Full distribution text Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
    • 5 Jul 2012 Z-0163-2013 Class II Terminated Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.via FDA establishment STRYKER SPINE Distribution: Nationwide distribution.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Stryker Spine CESTAS Nouvelle-Aquitaine · FR FEI 3003112432

Frequently asked questions

How many devices does Stryker Spine have in the registry?

The registry currently lists 73 devices for Stryker Spine. Devices recorded under merged duplicate company entries are counted once.

Which registries list Stryker Spine's devices?

Among its 50 most recently registered devices, Stryker Spine has devices listed in FDA 510(k) (50 devices).

What risk classes do Stryker Spine's devices fall under?

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

Are there FDA recall records for Stryker Spine?

FDA recall records list 99 recalls initiated by Stryker Spine, the most recent initiated on 28 Feb 2025. 6 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 Stryker Spine in the registry?

The most recently registered devices listed for Stryker Spine include Tritanium® C Anterior Cervical Cage, MODIFICATION TO XIA 4.5 SPINAL SYSTEM, XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi and MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL.

Which FDA establishments are linked to Stryker Spine?

1 FDA establishment is linked to Stryker Spine in the registry; they are listed on the company page.

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