FDA Device recall Z-1629-2024
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D by Howmedica Osteonics, citing the acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1629-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-27 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
Reason
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Identifiers
| code_info | UDI-DI:(01)07613327381009(17)290313(10) Lot Number: 14593551 15432653 15432651 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1629-2024%22
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