Howmedica Osteonics (Stryker) is recalling 321 Trident II Hemi and PSL Cluster acetabular shells because the edges may have been smoothed down too much during manufacturing. These medical devices are intended for use in hip replacement surgeries for patients at high risk of hip dislocation. If the shell surface is too smooth, it may not perform as intended during or after surgical implantation.
The excessive deburring on the edge of the shell creates an unintended smooth surface. This defect could potentially impact the fixation or stability of the hip implant, which may lead to complications for patients undergoing primary or revision hip surgery.
Manufacturer Notification and Guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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