PlainRecalls
FDA Devices Moderate Class II Ongoing

TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F

Reported: May 1, 2024 Initiated: February 27, 2024 #Z-1626-2024

Product Description

TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F

Reason for Recall

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

Details

Recalling Firm
Howmedica Osteonics Corp.
Units Affected
0
Distribution
Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F. Recalled by Howmedica Osteonics Corp.. Units affected: 0.
Why was this product recalled?
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Which agency issued this recall?
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1626-2024.