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Catalyft™ LS Expandable Interbody System 981027722Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 981027722 6MM ANT EXPANDABLE LG · Class 2 · Implant

All models of Catalyft LS Expandable Interbody System (6)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K212653); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Jun 6, 2023Class IIOpen, Classified

    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.

    Z-2121-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212653. One submission often covers many models, so check the product and lot details in each record.

  • Z-2119-2023 · Jun 6, 2023 · Open, Classified
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
  • Z-2117-2023 · Jun 6, 2023 · Open, Classified
    Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
  • Z-2118-2023 · Jun 6, 2023 · Open, Classified
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
  • Z-2122-2023 · Jun 6, 2023 · Open, Classified
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
  • Z-2123-2023 · Jun 6, 2023 · Open, Classified
    Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
  • Z-2120-2023 · Jun 6, 2023 · Open, Classified
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant

Other Intervertebral fusion device with bone graft, lumbar devices

All Intervertebral fusion device with bone graft, lumbar devices →

Sources and updates

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