Medtronic recalls a specific spinal implant model due to potential improper fit during surgery, which could affect patient anatomy. Affected units have unique identifiers and lot numbers.
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 the spine during surgery. This could lead to complications for patients needing spinal fusion procedures.
The implant may have incorrect dimensions (widths, lengths, heights, or angles) that don't match the patient's spine. This could cause improper support or correction during spinal fusion surgery, potentially leading to complications.
Patients who received this specific spinal implant during surgery are affected. Surgeons and medical facilities using the recalled model are at risk of complications during procedures.
Check for the unique identifier (UDI/DI) 00763000465919 and lot numbers NM21K050 or NM22B007 on the implant. This model is used for spinal fusion procedures.
Reach out to your surgeon to determine if you received the recalled implant model.
The recall indicates a potential for improper fit during surgery, but the exact risk level is not specified in the official notice.
Contact your surgeon to check if you received the recalled model; the official notice does not provide specific action steps for patients.
Look for the unique identifier (UDI/DI) 00763000465919 and lot numbers NM21K050 or NM22B007 on the implant.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2122-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2122-2023 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.
