FDA-Device2020-02-19Class II
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
Stryker Corporation
Hazard
Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used.
Sold states
US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI
Affected count
87 devices
Manufactured in
5900 Optical Ct, San Jose, CA, United States
Products
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1148-2020Don't want to check this manually?
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