Orthofix recalls three spinal implant models due to mislabeled anterior height (10mm vs 10.5mm). This could affect spinal fusion surgery accuracy. Contact Orthofix for details.
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
Orthofix is recalling three specific spinal fusion implants because they're labeled with the wrong height (10mm instead of 10.5mm). This labeling error might cause improper spinal fusion during surgery. Patients using these implants should contact Orthofix for guidance.
The implants are mislabeled with a height of 10mm, but they should be 10.5mm. This discrepancy could lead to improper spinal fusion during surgery if the wrong size is used. However, the error is only in labeling, not the physical implant dimensions.
Patients who received one of the three recalled spinal implants (model numbers REF 82-3300SP, 82-3700SP, or 82-4000SP) during surgery are likely affected. Surgeons and medical staff who used these implants are at highest risk.
Check if your implant has the model numbers REF 82-3300SP, 82-3700SP, or 82-4000SP with a height of 10mm. The specific lot numbers and UDI codes are listed in the recall notice.
Reach out to Orthofix directly for guidance on whether your implant is affected and next steps.
The recall is for labeling accuracy, not a physical defect. The risk is low as the implants themselves are correct, but the labeling error could affect surgical precision.
Check for model numbers REF 82-3300SP, 82-3700SP, or 82-4000SP with a height of 10mm on your implant's label.
The recall does not require returning the implant; contact Orthofix for specific guidance.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-1432-2025 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-1432-2025 from Orthofix. 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.
