Medtronic recalls specific spinal implant models due to potential fit issues that could affect surgery outcomes. Affected units include REF 981023325 with UDI 00763000465872 and lot numbers NM21J004, NM22A032.
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 in patients' spines during surgery. This could lead to improper bone graft support and affect spinal fusion results. Patients who received this implant should contact Medtronic for details.
The implant may have incorrect dimensions (width, length, height, or spinal angle) that don't match a patient's spine. This could cause improper bone graft support during spinal fusion surgery, potentially leading to failed fusion or complications.
Patients who received the Medtronic Catalyft LS Expandable Interbody System with the specified reference number and lot numbers during spinal surgery are affected. Surgeons and medical staff who used this implant are at higher risk.
Check for the reference number REF 981023325 and lot numbers NM21J004 or NM22A032 on the implant's packaging or documentation. The unique device identifier (UDI) 00763000465872 is also associated with this recall.
Reach out to Medtronic directly for specific instructions about your implant and whether it's affected by this recall.
The recall indicates potential fit issues that could affect surgery outcomes, but the implant is not unsafe for use unless it has the specific reference number and lot numbers mentioned in the recall.
Check for the reference number REF 981023325 and lot numbers NM21J004 or NM22A032 on the implant's packaging or documentation. The unique device identifier (UDI) 00763000465872 is also associated with this recall.
Contact Medtronic directly for specific instructions about your implant and whether it's affected by this recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2118-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2118-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
