Catalyft™ LS Expandable Interbody System 981023322Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000465865), received between Jul 14, 2022 and Jul 9, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Recalls naming this device

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-2117-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, 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 ↗

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-2118-2023 · Jun 6, 2023 · Open, Classified
  Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
• Z-2121-2023 · Jun 6, 2023 · Open, Classified
  Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
• Z-2122-2023 · Jun 6, 2023 · Open, Classified
  Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
• Z-2120-2023 · Jun 6, 2023 · Open, Classified
  Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
• Z-2119-2023 · Jun 6, 2023 · Open, Classified
  Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, 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