medical Class II Updated 2020-02-19

Stryker Corporation recalls Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double

Recalled Product

Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197

Hazard / Issue

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.

Issued by

FDA

Affected States: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI
Lot/Code Info: 19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.
View official government recall

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