FDA-Device2022-03-09Class II
Everest MI XT Inner Dilator, Catalog Number 5101-90167
K2M, Inc
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.
Sold states
Worldwide distribution - US Nationwide.
Affected count
686 Total Devices
Manufactured in
600 Hope Pkwy SE, Leesburg, VA, United States
Products
Everest MI XT Inner Dilator, Catalog Number 5101-90167
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0705-2022Don't want to check this manually?
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