K2M recalls Everest MI XT Inner Dilators (Catalog 5101-90167) due to improper fit during surgery. Affected units may not assemble correctly, risking surgical complications.
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
K2M is recalling Everest MI XT Inner Dilators (Catalog Number 5101-90167) because some units don't fit together properly during surgery. This could lead to surgical complications if the dilators fail to assemble correctly.
The dilators may not fit together properly during surgery due to a manufacturing issue. This could cause the surgical instruments to become misaligned or fail to function as intended, potentially leading to complications.
Surgical teams using Everest MI XT Inner Dilators from specific lots (JUJF, KFMV, KUPG, KYYU, MDRB, NDMK, NDMX, NXJK) are affected. Surgeons and medical staff using these units during procedures are at risk.
Check the catalog number (5101-90167) and lot numbers (JUJF, KFMV, KUPG, KYYU, MDRB, NDMK, NDMX, NXJK) on the product packaging. The product is sold under K2M, Inc. as the Everest MI XT Inner Dilator.
Verify the lot number on the packaging to see if it matches the affected lots: JUJF, KFMV, KUPG, KYYU, MDRB, NDMK, NDMX, NXJK.
K2M received two complaints about units from specific lots not fitting together properly during surgery. Additional units from other lots were later found to have the same manufacturing issue.
Check the lot number on the packaging. If it matches the affected lots (JUJF, KFMV, KUPG, KYYU, MDRB, NDMK, NDMX, NXJK), contact K2M for further instructions.
The recall record does not specify a remedy. Affected units should be checked against the listed lot numbers.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-0705-2022 — K2M K2M Hello, I own a K2M that is covered by recall Z-0705-2022 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.
