Medtronic recalls specific spinal implant models due to possible incorrect dimensions that could affect surgery safety. Affected units include REF 981025522 with UDI/DI 00763000465889 and lot numbers NM21J039, NM21M026.
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 have incorrect dimensions that could affect how it fits during surgery. This could lead to improper support for spinal fusion procedures, potentially causing complications for patients.
The implant may have incorrect widths, lengths, heights, or angles that don't properly fit a patient's spine. This could lead to improper support during spinal fusion surgery, potentially causing complications like instability or misalignment.
Patients who received the recalled spinal implant during surgery are affected. Surgeons and medical facilities using this specific model are at risk of complications during procedures.
Check for the product reference number REF 981025522 and the unique device identifier UDI/DI 00763000465889. Lot numbers NM21J039 and NM21M026 are also associated with this recall.
Verify the product reference number REF 981025522 and unique device identifier UDI/DI 00763000465889 on the implant.
The recalled model is Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage with reference number REF 981025522.
The lot numbers for the recalled implants are NM21J039 and NM21M026.
The recall record does not specify a remedy.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2119-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2119-2023 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.
