Catalyft™ LS Expandable Interbody System 981025522Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000465889), received between Apr 18, 2022 and Apr 18, 2022 — classified as 1 injury.

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-2119-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

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-2120-2023 · Jun 6, 2023 · Open, Classified
  Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, 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-2117-2023 · Jun 6, 2023 · Open, Classified
  Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, 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