Z-1147-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- July 19, 2019
- Termination Date
- February 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73 devices
Product Description
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
Reason for Recall
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.
Distribution Pattern
US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI
Code Information
19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.