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K2M, Inc recalls Everest MI XT Outer Dilator, Catalog Number 5101-90168
Recalled March 9, 2022 · FDA recall Z-0706-2022 · K2M
Hazard
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. · FDA Class II
Units
686 Total Devices
Sold at
Worldwide distribution - US Nationwide.
Description
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.
Product
Everest MI XT Outer Dilator, Catalog Number 5101-90168
Manufacturer(s)
K2M, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →