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Allez Spine, LLC

United StatesFDA applicant, unverified

Devices
7
FDA recalls
30

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Allez Spine, LLC makes

Allez Spine, LLC manufactures spinal fixation hardware, including monoaxial and polyaxial pedicle screw systems, cross connectors, and size-specific pedicle screws designed for spinal stabilization procedures. The Laguna and Del Mar series are intended for use in posterior spinal fusion surgeries, providing rigid or flexible fixation options depending on the screw type.

The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. All products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue7

Newest first, rows 1-7 of 7

FDA recalls30

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

Showing the 10 most recent of 30 recalls.

  • 2008

    • 21 Aug 2008 Z-0153-2009 Unclassified (pre-2012) Terminated This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA. Distribution: Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT. Submission number: K050060
    • 21 Aug 2008 Z-0154-2009 Unclassified (pre-2012) Terminated This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA. Distribution: Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT. Submission number: K051275
    • 21 Aug 2008 Z-0155-2009 Unclassified (pre-2012) Terminated This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA. Distribution: Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT. Submission number: K070460
    • 14 Apr 2008 Z-1819-2008 Unclassified (pre-2012) Terminated This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these parameters in performing cleaning, decontamination and sterilization procedures may not result in clean and sterile product. Distribution: Nationwide to AZ, CA, CO, GA, IL, NV, TN, TX, UT Submission number: K050060
    • 14 Apr 2008 Z-1820-2008 Unclassified (pre-2012) Terminated This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these parameters in performing cleaning, decontamination and sterilization procedures may not result in clean and sterile product. Distribution: Nationwide to AZ, CA, CO, GA, IL, NV, TN, TX, UT Submission number: K051275

  • 2007

    • 7 Nov 2007 Z-2060-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2061-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2062-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2063-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2064-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
Show the 25 most recent of 30 recalls

  • 2007

    • 7 Nov 2007 Z-2065-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2066-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2067-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2068-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2069-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2070-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2071-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2072-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2073-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2074-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2075-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2076-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2077-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 7 Nov 2007 Z-2078-2008 Unclassified (pre-2012) Terminated This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct. Distribution: Nationwide to AZ, CA, CO & UT Submission numbers: K050060, K051275
    • 30 Jul 2007 Z-0186-2008 Unclassified (pre-2012) Terminated Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation. Distribution: Nationwide: including the states of AZ, CA, CO, GA, NV, TX and UT Submission number: K050060

Frequently asked questions

How many devices does Allez Spine, LLC have in the registry?

The registry currently lists 7 devices for Allez Spine, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Allez Spine, LLC's devices?

Among its 7 most recently registered devices, Allez Spine, LLC has devices listed in FDA 510(k) (7 devices).

What risk classes do Allez Spine, LLC's devices fall under?

Among its 7 most recently registered devices, the classes recorded for Allez Spine, LLC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Allez Spine, LLC?

FDA recall records list 30 recalls initiated by Allez Spine, LLC, the most recent initiated on 21 Aug 2008. 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 Allez Spine, LLC in the registry?

The most recently registered devices listed for Allez Spine, LLC include LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM, ALLEZ SPINE CROSS CONNECTORS, LAGUNA SIZE 8 PEDICLE SCREW and LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM.

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