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Recall Observatory FDA recall evidence

Device product

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant

Z-2121-2023

June 06, 2023

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 92567
Status
Ongoing
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-2121-2023

Official wording

Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

Code information: UDI/DI 00763000465902, Lot Numbers: NM21K049

Distribution pattern: US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification