Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker Recalled by Stryker Corporation Due to Complaints have been received regarding difficulty in removing...
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 Stryker Corporation directly.
Affected Products
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
Quantity: 87 devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 19 states: AK, AZ, AR, CA, CO, FL, GA, ID, IL, KY, ME, MD, NV, NJ, NY, OH, TX, UT, WI
About Stryker Corporation
Stryker Corporation has 108 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report