Medtronic recalls specific spinal implant models due to possible improper device geometry affecting surgery. Affected units may not fit patient anatomy correctly, requiring replacement.
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.
Medtronic is recalling a specific spinal implant model because it may not fit properly during surgery. This could lead to improper spinal fusion and complications for patients needing back surgery.
The implant may have incorrect dimensions (widths, lengths, heights, or angles) that don't match patient anatomy. This could cause improper spinal fusion during surgery, potentially leading to complications.
Patients who received the recalled spinal implant during surgery are affected. Surgeons and hospitals using this specific model for lumbar fusion procedures are at risk.
Check for the model name 'Catalyft LS Expandable Interbody System, Anterior Standalone Cage' with reference number 981027722. The implant was used in lumbar fusion surgeries between 2021 and 2022.
Reach out to your surgeon to confirm if you received the recalled implant model during surgery.
The recall indicates potential fit issues during surgery, but the implant itself is not dangerous if used correctly. Consult your surgeon for specific concerns.
Check for the model name 'Catalyft LS Expandable Interbody System, Anterior Standalone Cage' with reference number 981027722. The implant was used in lumbar fusion surgeries between 2021 and 2022.
Contact your surgeon to determine if you received the recalled model and follow their guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2121-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2121-2023 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.