K2M recalls specific lumbar fusion implants due to incorrect size labeling that could lead to improper surgical fit. Affected products have catalog number 6101-210281: 10x22x14mm, 10x28x14mm, 10x22x15mm. Check your lot numbers for recall.
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
K2M is recalling certain lumbar spinal implants because their size labels are incorrect. This could lead to improper surgical fitting if used in procedures. Affected products include specific model sizes with catalog number 6101-2102814NC-G2.
The implants have incorrect size labels for specific lots and sizes. This could lead to improper surgical fitting if the wrong size is used during spinal fusion procedures. However, the hazard is limited to labeling errors and does not involve immediate safety risks.
Patients who received these specific lumbar spinal implants for fusion surgery are affected. Surgeons and medical facilities using the recalled models are at risk of improper surgical outcomes.
Check the product's catalog number: 6101-2102814NC-G2. Look for specific sizes: 10x22x14mm, 10x28x14mm, or 10x22x15mm. The lot number for affected items is NCNE-4437924.
Look for the catalog number 6101-2102814NC-G2 and specific sizes: 10x22x14mm, 10x28x14mm, or 10x22x15mm.
No, the hazard is a labeling error that could lead to improper surgical fitting if the wrong size is used, but it does not pose an immediate safety risk.
Check the product label for the catalog number and specific sizes to see if you are affected. If you are affected, contact K2M directly for further instructions.
Look for the catalog number 6101-2102814NC-G2 and specific sizes: 10x22x14mm, 10x28x14mm, or 10x22x15mm. The lot number for affected items is NCNE-4437924.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-1697-2021 — K2M K2M Hello, I own a K2M that is covered by recall Z-1697-2021 from K2M. 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.
