Lower risk Medical device recall · FDA · Published January 13, 2022

K2M Everest MI XT Inner Dilator Recall: Improper Fit During Surgery

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0705-2022Medical device K2M ›

Lower-risk recall

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.

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Contact the company

Recalling firmK2M, Inc600 Hope Pkwy SE · Leesburg, VA 20175-4428

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61267-k2m-everest-mi-xt-inner-dilator-recall-improper-fit-during.

Source Summary by GovInfoNow · govinfonow.com/recall/61267-k2m-everest-mi-xt-inner-dilator-recall-improper-fit-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0705-2022

Cite this page

“K2M Everest MI XT Inner Dilator Recall: Improper Fit During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61267-k2m-everest-mi-xt-inner-dilator-recall-improper-fit-during. Based on FDA recall #Z-0705-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0705-2022%22&limit=1).

The FDA announced on Jan. 13, 2022, that K2M, Inc. is recalling Everest MI XT Inner Dilators due to a manufacturing nonconformance causing units to not fit together properly during surgery. The agency issued recall number Z-0705-2022 for the Class II device.

How to tell if you have it

Brand: K2M
Product: Everest MI XT Inner Dilator
Catalog Number: 5101-90167
UPC: 10888857261204
Lot Numbers: JUJF, KFMV, KUPG, KYYU, MDRB, NDMK, NDMX, NXJK

The hazard

Stryker reported two complaints regarding units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and others were determined to be affected by a manufacturing nonconformance.

Context

GovInfoNow's records show K2M, Inc. has had 10 other recalls since July 24, 2018. Other recent recalls include the K2M Yukon Straight Rod 4.0x120mm (June 13, 2022), the K2M Chesapeake AL Removal Tool (Sept. 8, 2021), and the K2M Cascadia AN Interbody Convex Implants (May 7, 2021). Similar product recalls include the Diversatek Viper 3-Stage Balloon Dilator (March 18, 2026) and the Medtronic Octopus 4 Tissue Stabilizer Model 29400 (May 12, 2026).

How to tell if you have this one

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.

Brand
K2M
Product
K2M, Inc recalls Everest MI XT Inner Dilator, Catalog Number 5101-90167
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide.

Recall number	Product, codes & lots
Z-0705-2022	Everest MI XT Inner Dilator, Catalog Number 5101-90167; GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK
Z-0706-2022	Everest MI XT Outer Dilator, Catalog Number 5101-90168; GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Verify the lot number on the packaging to see if it matches the affected lots: JUJF, KFMV, KUPG, KYYU, MDRB, NDMK, NDMX, NXJK.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 55 days after the firm started it.

Jan 13, 2022Firm started the recall
Mar 1, 2022FDA classified it Class II
Mar 9, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61267-k2m-everest-mi-xt-inner-dilator-recall-improper-fit-during">K2M Everest MI XT Inner Dilator Recall: Improper Fit During Surgery (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0705-2022 (January 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0705-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.