Medtronic recalls specific spinal implant models due to potential for improper device geometry affecting surgery. This could lead to inadequate spinal fusion support. Affected units include REF 981023322 with UDI/DI 00763000465865 and lot numbers NM21J001, NM21J014.
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 that may not fit properly during surgery. This could lead to inadequate spinal fusion support and potentially require additional procedures. Patients with this implant should contact Medtronic for guidance.
The implant may have incorrect dimensions (widths, lengths, heights, or angles) that don't match the patient's spine. This could result in improper spinal fusion support during surgery, potentially requiring additional procedures to correct the issue.
Patients who received the Medtronic Catalyft LS Expandable Interbody System with REF 981023322 and UDI/DI 00763000465865 are affected. Surgeons and medical staff who used this implant in procedures between specific dates are at higher risk.
Check for the product reference number REF 981023322 and the unique device identifier UDI/DI 00763000465865. The lot numbers NM21J001 and NM21J014 are also associated with this recall.
Reach out to Medtronic directly to confirm if your implant is affected and get instructions for next steps.
This recall is for potential improper fit during surgery, not an immediate risk to patients. Only those with the specific implant model are affected.
Contact Medtronic to confirm if your implant is affected and follow their instructions for next steps.
Look for the product reference number REF 981023322 and the unique device identifier UDI/DI 00763000465865 on your implant packaging or documentation.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2117-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2117-2023 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.
