Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Everest MI XT Outer Dilator Recalled by K2M, Inc Due to Stryker received two (2) complaints for units from...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact K2M, Inc directly.
Affected Products
Everest MI XT Outer Dilator, Catalog Number 5101-90168
Quantity: 686 Total Devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About K2M, Inc
K2M, Inc has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report