K2M recalls Everest MI XT Outer Dilators (Catalog 5101-90168) 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 Outer Dilators (Catalog Number 5101-90168) 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 can cause the surgical instruments to become misaligned or fail to function as intended, potentially leading to complications.
Surgical teams using Everest MI XT Outer Dilators from specific lots may be affected. Patients undergoing procedures with these dilators could face complications if the units don't assemble correctly.
Check for the catalog number 5101-90168 on the product. Affected units have lot numbers: HCBN, HCBP, JUJJ, KFMX, KUPH, KYYV, MDPF, NAKJ, NDGT, PCCN.
Identify the lot number on the product label to determine if it is affected (HCBN, HCBP, JUJJ, KFMX, KUPH, KYYV, MDPF, NAKJ, NDGT, PCCN).
Stryker received two complaints about units from specific lots not fitting together during surgery. Additional units from other lots were later found to be affected by a manufacturing issue.
The recall record does not specify a remedy, so no action is required beyond checking the lot number.
Check the lot number on the product label. Affected units have lot numbers: HCBN, HCBP, JUJJ, KFMX, KUPH, KYYV, MDPF, NAKJ, NDGT, PCCN.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-0706-2022 — K2M K2M Hello, I own a K2M that is covered by recall Z-0706-2022 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.
