Catalyft LS Expandable Interbody SystemRecalls & reported problems across all models

We found 6 models of Catalyft LS Expandable Interbody System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2022 and Jul 9, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Catalyft LS Expandable Interbody System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 6, 2023Open, 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-2122-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 6, 2023Open, 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 ↗

3. Jun 6, 2023Open, 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-2120-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jun 6, 2023Open, 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-2119-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Jun 6, 2023Open, 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-2118-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Jun 6, 2023Open, 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-2117-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Catalyft LS Expandable Interbody System problems

Catalyft LS Expandable Interbody System models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Catalyft™ LS Expandable Interbody System 981023322

  Intervertebral fusion device with bone graft, lumbar
  1 recall2 reports
• Catalyft™ LS Expandable Interbody System 981025522

  Intervertebral fusion device with bone graft, lumbar
  1 recall1 report
• Catalyft™ LS Expandable Interbody System 981023325

  Intervertebral fusion device with bone graft, lumbar
  1 recall0 reports
• Catalyft™ LS Expandable Interbody System 981025525

  Intervertebral fusion device with bone graft, lumbar
  1 recall0 reports
• Catalyft™ LS Expandable Interbody System 981027722

  Intervertebral fusion device with bone graft, lumbar
  1 recall0 reports
• Catalyft™ LS Expandable Interbody System 981027725

  Intervertebral fusion device with bone graft, lumbar
  1 recall0 reports

Recent Catalyft LS Expandable Interbody System adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A S TANDARD AND POSTERIOR ALIF L4-S1 IN A PATIENT DIAGNOSED WITH L4-L5-S1 SPONDYLOLOTHESIS AND COLLAPSED HEIGHT. IT WAS REPORTED THAT CAGES AT BOTH LEVELS COLLAPSED FROM BOTH INTRA OP AND POST OP IMAGING. PATIENT IS DOING WELL, BUT COLLAPSED CAGES HAVE LED TO BROKEN P OSTERIOR SCREWS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458152 ↗
• MalfunctionJul 14, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L5/S1 ALIF PROCEDURE IN A PATIENT DIAGNOSED WITH SPONDYLOTHESIS. IT WAS REPORTED THAT THE PLATE BROKE OFF FROM THE CAGE. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15011447 ↗
• InjuryApr 18, 2022Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING PATIENT FOR OLIF 5/1 SPINAL THERAPY. IT WAS REPORTED THAT THE PARTS OF CAGE CAME APART FROM DEVICE AND FELL OFF WHEN TRYING TO PLACE SCREWS IN TAB HOLES. CAGE WAS LEFT IN PATIENT AS SURGEON COULDN¿T GET IT BACK OUT. FLIPPED THE PATIENT OVER AND USED O-ARM TO DO MAZOR SCAN AND PLAN TO LOCK DOWN FROM THE BACK USING VOYAGER SCREWS. THE PART CAME IN CONTACT WITH PATIENT. THERE WAS A DELAY IN ACTUAL CASE OF 20-30 MINUTES. A REVISION DONE ON 3/28 TO REMOVE CAGE AND PLACE A DIFFERENT CAGE IN ITS PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14133762 ↗

Other Medtronic Sofamor Danek, Inc. products

• CD HORIZON Spinal System342 models · 2,323 reports
• GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
• METRx System5 models · 672 reports
• INFUSE Bone Graft6 models · 576 reports · 1 recall
• CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
• POWEREASE Instruments8 models · 331 reports · 1 recall
• Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
• INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls