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Recall Observatory FDA recall evidence

Device product

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

Z-1147-2020

July 19, 2019

Class II

Product summary

Firm
Stryker Corporation
Event
Event 84664
Status
Terminated
Classification
Class II
Quantity
73 devices
Official record key
device-enforcement:Z-1147-2020

Official wording

Reason: 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.

Code information: 19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.

Distribution pattern: US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.