Class II

Medical Device Recall: TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E

Howmedica Osteonics Corp. · February 27, 2024

Reason for Recall

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Distribution

Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

States Affected

NATIONWIDE

Quantity Affected

3 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1630-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.