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Synthes Spine

Country not established

Devices
30
FDA recalls
13

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Synthes Spine makes

Synthes Spine manufactures spinal fixation and stabilization systems, including polyaxial screws, pedicle/sacral screws, spinal hooks, rods, and interbody spacers for both adult and pediatric use. Their portfolio includes posterior and anterior lumbar and thoracic fixation devices, as well as specialized systems for the cervical spine and iliosacral region. Additional offerings include modular components for spinal reconstruction, such as the VECTRA-ONE lateral access system and anterior thoracolumbar rod clamps.

The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) database. Synthes Spine operates as a subsidiary based in the United States.

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

Catalogue30

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Rows 1-30 of 30

FDA recalls13

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

FDA recall records list 13 recalls initiated by Synthes Spine, the earliest on 2008-11-07 and the most recent on 2009-04-03. By recorded status: 13 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, electrical or power, mechanical integrity and manufacturing or quality process. 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.

Showing the 10 most recent of 13 recalls.

  • 2009

    • 3 Apr 2009 Z-1640-2009 Unclassified (pre-2012) Terminated Sterility may be compromised due to a ineffective package design. Distribution: Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA,…
      Full distribution text Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the country of Canada.
      Submission number: K021458
    • 3 Apr 2009 Z-1641-2009 Unclassified (pre-2012) Terminated Sterility may be compromised due to a ineffective package design. Distribution: Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA,…
      Full distribution text Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the country of Canada.
      Submission number: K021458
    • 10 Feb 2009 Z-1348-2009 Unclassified (pre-2012) Terminated Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening. Distribution: Distributed Nationwide and Canada. Submission number: K072981
    • 9 Feb 2009 Z-1324-2009 Unclassified (pre-2012) Terminated Numbers are etched incorrectly on the product. Distribution: Worldwide Distribution -- US (states of AR, CA, CO, CT, FL, IA, IL, LA, MD, ME, MI, MN, MS, NJ, NY, OK, PA, SC, TX, and…
      Full distribution text Worldwide Distribution -- US (states of AR, CA, CO, CT, FL, IA, IL, LA, MD, ME, MI, MN, MS, NJ, NY, OK, PA, SC, TX, and UT) and country of Switzerland.
      Submission number: K051600

  • 2008

    • 18 Dec 2008 Z-1248-2009 Unclassified (pre-2012) Terminated The bender is heating prior to activation of the power button, requiring disassembly to stop heating. Distribution: Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT Submission number: K021458
    • 18 Dec 2008 Z-1249-2009 Unclassified (pre-2012) Terminated The bender is heating prior to activation of the power button, requiring disassembly to stop heating. Distribution: Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT Submission number: K021458
    • 20 Nov 2008 Z-0931-2009 Unclassified (pre-2012) Terminated screwdriver tip may break off and lodge in the screw head Distribution: Class II Recall - Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS,…
      Full distribution text Class II Recall - Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA ,SC, TN, TX, UT, VA, WA, and WI, and countries of Canada and Switzerland.
      Submission number: K072253
    • 7 Nov 2008 Z-0963-2009 Unclassified (pre-2012) Terminated the dimensional specifications are incorrect Distribution: Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR,…
      Full distribution text Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.
      Submission number: K061774
    • 7 Nov 2008 Z-0964-2009 Unclassified (pre-2012) Terminated the dimensional specifications are incorrect Distribution: Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR,…
      Full distribution text Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.
      Submission number: K061774
    • 7 Nov 2008 Z-0965-2009 Unclassified (pre-2012) Terminated the dimensional specifications are incorrect Distribution: Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR,…
      Full distribution text Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.
      Submission number: K072685
Show all 13 recalls

  • 2008

    • 7 Nov 2008 Z-0966-2009 Unclassified (pre-2012) Terminated the dimensional specifications are incorrect Distribution: Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR,…
      Full distribution text Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.
      Submission number: K072685
    • 7 Nov 2008 Z-0967-2009 Unclassified (pre-2012) Terminated the dimensional specifications are incorrect Distribution: Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR,…
      Full distribution text Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.
      Submission number: K072685
    • 7 Nov 2008 Z-0968-2009 Unclassified (pre-2012) Terminated the dimensional specifications are incorrect Distribution: Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR,…
      Full distribution text Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.
      Submission number: K072685

Frequently asked questions

How many devices does Synthes Spine have in the registry?

The registry currently lists 30 devices for Synthes Spine. Devices recorded under merged duplicate company entries are counted once.

Which registries list Synthes Spine's devices?

Among its 30 most recently registered devices, Synthes Spine has devices listed in FDA 510(k) (30 devices).

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

Among its 30 most recently registered devices, the classes recorded for Synthes Spine's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Synthes Spine?

FDA recall records list 13 recalls initiated by Synthes Spine, the most recent initiated on 2009-04-03. 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 Synthes Spine in the registry?

The most recently registered devices listed for Synthes Spine include USS ILIOSACRAL, USS POLYAXIAL, ORACLE SPACER, OPAL SPACER, SYNTHES MIRS and SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM.

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