Medtronic recalls specific spinal implant kits (REF SPS03188) due to possible incorrect device geometries that could affect spinal fusion surgery. Affected kits include lot numbers 0001-0029.
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 certain spinal implant kits for possible incorrect device geometries that might not fit properly during surgery. This could lead to improper spinal fusion if the implants don't match the patient's anatomy.
The implants may have incorrect widths, lengths, heights, or angles that don't match a patient's spine. This could cause improper spinal fusion during surgery if the implants don't fit the patient's anatomy correctly.
Surgical patients who received the specific spinal implant kits with lot numbers 0001-0029. Surgeons and hospitals using these kits are most at risk.
Check if your spinal implant kit has the reference number SPS03188 and lot numbers 0001 through 0029. This kit is used for lumbar spine fusion surgeries.
Identify if your implant kit has the reference number SPS03188 and lot numbers 0001-0029.
The recall is due to potential out of specification device geometries that might not fit properly during spinal fusion surgery.
Check if your kit has the reference number SPS03188 and lot numbers 0001-0029. If so, contact Medtronic for further instructions.
The recall addresses potential fit issues during surgery, but the hazard is not described as causing immediate injury in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2123-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2123-2023 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.
