Z-1630-2024 Class II Ongoing

Recalled by Howmedica Osteonics Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
May 1, 2024
Initiation Date
February 27, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

UDI-DI: (01)07613327381023(17)290313(10) Lot Number: 14876553 14876552