Medtronic recalls specific spinal implants due to potential improper fit during surgery. The recall involves devices with certain model numbers and lot codes. Affected patients should contact Medtronic for guidance.
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 due to a risk that the device might not fit properly in the body during surgery. This could lead to complications in spinal fusion procedures if the implant doesn't match the patient's anatomy.
The spinal implant may have incorrect dimensions or angles, which could lead to improper fitting during surgery. This might cause the implant to not support the spine correctly, potentially affecting the fusion process.
Patients who received the specific spinal implant model with lot numbers NM21K046, NM21L032, or NM22A042 are affected. Surgeons and medical staff using these implants during procedures are also at risk.
Check for the lot numbers NM21K046, NM21L032, or NM22A042 on the implant's packaging or documentation. The product is a spinal implant used in lumbar fusion surgeries.
Reach out to Medtronic directly for guidance on next steps and whether the implant needs to be replaced.
The recall states there is a potential for improper fit during surgery, but the implant is designed to be used correctly by medical professionals.
Contact Medtronic directly for specific instructions based on your implant's details.
Look for the lot numbers NM21K046, NM21L032, or NM22A042 on the implant's 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-2120-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2120-2023 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.
