Howmedica Osteonics Corp.: Medical Device Recall in 2024 - (Recall #: Z-1628-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D

Product Classification:

Class II

Date Initiated: February 27, 2024

Date Posted: May 1, 2024

Recall Number: Z-1628-2024

Event ID: 94215

Reason for Recall:

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

Status: Ongoing

Product Quantity: 0

Code Information:

UDI-DI: (01)07613327380941(17)290313(10) Lot Number: 16311453

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated