FDA recall Z-1622-2024

Howmedica Osteonics Corp. · Class II · device

Product

TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D

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

Key facts

Status
Ongoing
Initiation date
2024-02-27
Report date
2024-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1622-2024